[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OLO":3},{"classification":4,"mappedDevices":944,"similarCandidates":945,"relatedClassifications":1027,"syncDates":1071},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":937,"updated_at":938,"recall_count":939,"latest_recall_date":940,"k510_count":941,"pma_count":942,"event_count":943},658,"OLO","Orthopedic Stereotaxic Instrument","2","882.4560","NE","Neurology","OR","1","Stereotaxic guidance during orthopedic surgery procedures.  Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":934,"device_class":8,"implant_flag":935,"product_code":6,"review_panel":12,"gmp_exempt_flag":935,"third_party_flag":935,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":934,"life_sustain_support_flag":935,"medical_specialty_description":11,"summary_malfunction_reporting":936},{"k_number":18,"fei_number":458,"registration_number":846},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457],"K252597","K120867","K192911","K230064","K230716","K220652","K153237","K251316","K152041","K240062","K181449","K172219","K163581","K092497","K181890","K170977","K232345","K190556","K241644","K240139","K183644","K253444","K110054","K170584","K261665","K222383","K243659","K203005","K243258","K233255","K254157","K220241","K253604","K253381","K200845","K241625","K261113","K220593","K110021","K242806","K170937","K200642","K083310","K130387","K252989","K191285","K242009","K111843","K140331","K103400","K163379","K252037","K162937","K160713","K200047","K210668","K220973","K190653","K191223","K083009","K151511","K163221","K220255","K210457","K102967","K193618","K193307","K171525","K121936","K240721","K153603","K171267","K230876","K233254","K173372","K233595","K213720","K260546","K191100","K182848","K181606","K241031","K193094","K232140","K230861","K243387","K203679","K212245","K210555","K240701","K173338","K191943","K251073","K162341","K180038","K242373","K182721","K260601","K211616","K223767","K243419","K213546","K192526","K091411","K090953","K241082","K252880","K191507","K202552","K222753","K143668","K241130","K220291","K253921","K230880","K223511","K260369","K140454","K212825","K201022","K083483","K192663","K243671","K220024","K093206","K203110","K201251","K191039","K131425","K221180","K133759","K160537","K223070","K191854","K223200","K213033","K180277","K221928","K201569","K212007","K230243","K253623","K160385","K141941","K252950","K172301","K140596","K121064","K222510","K141601","K233513","K250182","K122326","K213380","K213918","K232802","K220146","K110204","K100599","K241893","K083644","K172849","K172034","K180307","K124004","K111811","K261410","K232533","K170360","K153647","K193135","K192133","K203561","K203573","K152574","K111443","K182524","K223350","K233542","K223808","K252562","K232521","K213708","K220958","K162195","K100742","K242914","K230202","K211442","K240211","K172522","K260329","K250608","K163338","K193515","K212088","K221224","K213876","K240951","K170430","K254158","K240662","K241171","K261060","K210472","K233299","K222698","K231886","K260582","K241011","K223765","K223351","K260011","K083872","K112507","K221618","K192173","K172166","K162962","K230369","K191722","K170280","K180796","K242121","K171321","K250879","K140927","K250167","K140167","K181111","K100107","K103829","K202769","K260480","K122742","K260571","K153203","K143752","K231963","K142530","K223558","K240160","K182964","K122011","K233725","K233638","K102990","K233706","K262121","K172268","K130748","K243481","K250520","K230195","K254148","K210574","K181596","K240625","K192140","K242264","K182104","K162921","K211596","K093118","K201189","K173946","K162375","K200935","K234047","K093998","K233256","K172623","K153396","K193128","K220348","K201966","K243073","K201255","K192653","K182731","K170891","K213877","K251315","K220038","K202320","K170593","K223301","K230989","K231184","K261024","K203040","K232800","K252871","K182982","K212537","K230700","K231172","K170581","K202836","K222291","K180352","K180271","K170011","K191369","K243751","K172517","K232413","K252962","K183381","K230087","K243514","K250086","K260240","K090420","K252841","K140689","K181848","K191998","K252873","K233227","K192080","K223553","K200376","K252742","K153240","K243326","K251282","K251314","K200892","K252087","K233199","K252755","K251943","K261852","K252058","K201006","K211441","K233228","K203751","K172462","K201327","K171780","K203205","K090313","K193120","K213491","K222966","K251971","K143628","K091998","K220522","K231494","K200095","K153700","K200719","K232116","K130887","K190881","K172518","K131130","K202184","K222355","K243285","K251060","K242890","K243560","K243814","K183196","K212756","K183605","K093425","K192495","K201661","K252088","K232572","K220862","K102251","K090375","K214011","K240647","K162364","K251780","K252544","K192336","K180816","K183630","K242864","K143597","K203115","K250877","K241517","K220774","K223649","K210121","K221028","K203291","K180690","K182077","K230180","K110240","K172115","K171651","K260010","K171556","K220459","K141989","K182345","K203816","K150231","K151364","K233443","K214059","K231527","K250599","K212023","K260222","K223927","K182121","K230783","K232044","K253661","K261205","K242464","K212028","K202749","K243958","K213873","K191012","K223108","K121765","K141694","K240568","K202956","K200791","K180523","K200888","K242933","K231229","K162567",[459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722,723,724,725,726,727,728,729,730,731,732,733,734,735,736,737,738,739,740,741,742,743,744,745,746,747,748,749,750,751,752,753,754,755,756,757,758,759,760,761,762,763,764,765,766,767,768,769,770,771,772,773,774,775,776,777,778,779,780,781,782,783,784,785,786,787,788,789,790,791,792,793,794,795,796,797,798,799,800,801,802,803,804,805,806,807,808,809,810,811,812,813,814,815,816,817,818,819,820,821,822,823,824,825,826,827,828,829,830,831,832,833,834,835,836,837,838,839,840,841,842,843,844,845],"3004727093","3007700286","3014411622","1221053","3026576110","3001237338","3004638600","3005985723","3006846753","3003935342","3009256700","3000719653","3004893332","3015877656","3009144915","3004641308","3000203466","3003569173","3010666513","3040335671","3005641619","3002743211","3009051471","1625507","3004635447","3012263546","3008027912","3002806685","3010032903","3033536319","3008583793","3001551180","3010120339","3002806725","3002807156","2648623","3013422238","3002806773","3001452082","3010287737","3002807421","3016443334","3013917867","3003637761","3016261131","3003015552","3007344102","3010097171","3009050824","1000139987","3009266751","3003525643","3017528621","3015876273","3003761012","3002462840","3003604053","1000517406","3009973336","3000215205","3009394448","3009973505","3010120326","3011656326","3010047402","3010370554","3010120148","3007539489","3005706667","3000205591","3014655115","3015907115","3008820440","3004060780","3016075969","3010197239","1828288","1219602","3014782362","3015967359","3010049501","1047843","3033536255","3010155648","3012227716","3024788684","3002807830","3006460162","1421101","3003128516","3007125392","3015542154","3004719693","3019878714","3039520898","3012764194","3010039400","1218017","3019767615","3002807328","3040312029","3010141593","3010462278","3010863450","3017980495","3004513872","3005012805","3016619943","3018094310","2528981","3009165919","3015869121","3010363503","3006654680","3010313588","3004153896","3011674645","3008110533","3012911444","3009049161","3009554293","3005497913","3016050940","1526439","3006639944","3009417901","3009887475","3010197224","3002926812","3005061536","3003640911","3012966183","3038503932","3014170143","3006125668","3012131184","3010938185","3006003617","3002806315","3008812560","3005180920","1220477","3006128100","1000522098","3009959868","3014680795","3005969827","3020703621","1000517638","3009433026","3004499989","3004976965","3003387384","3007014520","3014498598","3008342029","1000116116","3007282753","3008599177","3009522766","3030154790","1221485","1832656","1221763","2027487","3010663372","1000115331","3009493875","3015399803","3010531060","3000204692","3010120135","3007441485","3008837339","1935627","3007515069","3010232390","3002980729","3010822102","1000115656","3009971621","3000717687","3015536273","3017492965","3000203066","2183449","3007485169","3002807231","1018470","3013682146","3016496998","3000209794","3034676720","3019807891","2024311","3001236277","3016438694","3012447612","3021976927","3016090213","3005677016","1828464","3003120897","3003477135","3004717358","3003112432","1000138054","3010129044","3007521480","3011683674","3005874553","1000548922","3008992889","3000206435","3010408671","1721676","3007997036","3021902355","3003617485","3036756245","3009381600","3012120772","3012401682","3011187779","3009293341","3004608878","3008782585","3003714383","3015537048","3043543260","3011713200","3037407500","2081135","1000306340","3025603301","3005751028","3014273424","3002821504","3009337690","3012495575","1000221916","3002904345","3010120104","3014252644","1000136269","3021008900","3008397795","3011796723","3013302242","3025343017","3013485140","1928237","3008114965","3018565653","3011015572","3006776201","3004464325","3006984710","1824199","3001284227","3006791286","3005532635","3004369318","3008868758","3017406274","3009322142","3013552417","3006563559","3017123055","3016084569","1000132370","3002808269","1000477302","3009962553","1043653","3021948057","3023852420","1000116912","3009871135","3004181214","1450662","1000136478","3017565094","3009879967","3015207155","3041276509","3003164255","3005819474","3003541440","3004188066","3010009693","1526534","1720929","3009185973","1000117423","1000123143","3004016520","3011577940","3000215273","3005216725","3002929183","3015516266","3001049282","3025110439","3010041430","3010009632","3007728266","3025783933","3012639025","3043520111","3002795782","1000219637","1643264","1818910","3002619595","3001236549","3003179719","3010123206","3000270450","3003200961","3009973699","3007993775","3003596442","3009888740","3013194153","2246552","3015831087","3005739886","3027153110","3033509898","3005075696","3004024955","2027467","3002806577","3008647423","3015179588","3001592626","3001642380","3000717902","3014725904","3000210784","3003500271","3013422236","3017823294","3002807041","3004126422","3018405359","3011764740","3010986197","2011171","3030400539","3006493760","3014479313","1000306303","1045834","3007922509","3003678543","3020375573","3010047454","1020279","1314417","3027305794","2647346","3002807036","3008455034","3002907620","3005083075","3003639920","3012098629","3030412764","3009380063","3003139373","3021632375","3012429289","3004142400","2219920","3012428435","3001503333","3003661942","3010057495","3016678045","3001239363","1000135253","3011795235","3003955307","3003064967","3021060474",[459,460,461,462,463,465,847,467,468,470,471,848,472,473,474,849,850,478,851,852,479,480,853,481,482,854,483,855,856,484,485,487,488,857,489,491,494,495,498,500,501,502,503,505,506,507,509,510,511,512,513,858,859,515,516,517,519,520,521,860,522,523,524,525,526,527,529,530,532,533,861,534,535,862,536,537,863,538,539,540,541,542,543,544,546,547,549,550,864,551,552,553,865,554,866,555,867,556,557,559,560,868,561,562,563,564,565,566,869,567,568,870,569,570,571,871,572,573,574,575,576,577,578,872,579,580,873,581,582,583,874,584,585,586,588,590,591,592,875,593,594,598,599,600,601,876,603,604,877,878,606,879,608,609,610,880,611,612,881,613,618,619,620,622,623,624,882,883,626,627,884,885,628,630,631,886,632,633,634,887,635,888,637,639,889,641,890,642,644,645,891,892,647,648,649,651,893,652,653,655,656,657,658,659,660,661,894,662,663,895,896,666,667,668,669,670,671,673,897,898,674,899,675,676,900,901,677,902,678,679,680,903,681,682,683,684,687,688,689,690,904,691,905,693,906,694,695,907,697,698,908,701,702,704,706,707,708,709,710,711,712,713,714,715,716,717,718,719,909,722,723,725,910,726,911,727,728,912,913,914,732,915,733,734,735,737,738,739,916,741,917,742,918,743,744,919,746,747,748,749,750,751,752,920,755,756,758,760,762,763,764,765,766,767,768,921,771,922,772,923,924,776,777,925,779,926,780,781,782,783,784,785,786,787,788,789,790,791,927,928,794,795,798,800,801,802,804,805,807,808,809,810,811,813,814,815,816,817,818,819,820,821,823,824,825,826,827,828,829,830,831,832,833,834,929,835,930,931,837,838,839,840,932,842,843,933,845],"9614209","8031020","1833920","3011782009","3007366790","9617297","1649518","9617840","9610612","8043933","2134947","3009882675","1226544","9617544","2244478","3010041499","2133772","2031966","3004209178","2090010","9611112","2031917","1319639","2530808","1057425","1835251","1123169","9615128","1834379","1058584","2183946","2135156","9610622","1833986","3002807090","2531477","8043792","2031910","1833824","1835572","3010173425","3017410889","2133810","1423662","9612420","9611813","1834331","3013404959","8010177","2133641","9680515","1225492","1424434","1064858","3026776","3006783837","1056553","1835444","2031093","9611827","3004774118","2249615","2087234","2133786","2133928","3010162973","1319660","3015941638","1833506","2953359","1226188","1644408","9616696","1835296","1424263","8010916","1723170","3005823819","9611579","2134470","2030624","8010468","1030489","9611390","9612277","1836357","1721964","","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-19T02:39:39.426476+00:00",112,"2026-07-15",439,0,20203,[],[946,955,964,972,980,988,996,1004,1012,1019],{"medical_device_id":947,"generic_name":948,"class_classification":949,"jmdn_code":950,"name_similarity":951,"definition_similarity":952,"vector_similarity":953,"score":954},3918,"整形外科用骨セメント混合器","Ⅰ","33191000",0.291667,0.182979,0.647786,0.0291986,{"medical_device_id":956,"generic_name":957,"class_classification":958,"jmdn_code":959,"name_similarity":960,"definition_similarity":961,"vector_similarity":962,"score":963},2902,"整形外科装具挿入器","Ⅱ","13180000",0.392857,0.162577,0.634358,0.0287391,{"medical_device_id":965,"generic_name":966,"class_classification":949,"jmdn_code":967,"name_similarity":968,"definition_similarity":969,"vector_similarity":970,"score":971},4336,"関節手術用器械","70964001",0.236364,0.243655,0.674424,0.0277569,{"medical_device_id":973,"generic_name":974,"class_classification":949,"jmdn_code":975,"name_similarity":976,"definition_similarity":977,"vector_similarity":978,"score":979},4346,"整形外科用テープ","32882000",0.289474,0.134884,0.63916,0.0274436,{"medical_device_id":981,"generic_name":982,"class_classification":949,"jmdn_code":983,"name_similarity":984,"definition_similarity":985,"vector_similarity":986,"score":987},4330,"整形外科用バー","36249001",0.297297,0.204819,0.633446,0.0271997,{"medical_device_id":989,"generic_name":990,"class_classification":949,"jmdn_code":991,"name_similarity":992,"definition_similarity":993,"vector_similarity":994,"score":995},4306,"整形外科用リーマ","35297001",0.275,0.187793,0.639841,0.027027,{"medical_device_id":997,"generic_name":998,"class_classification":949,"jmdn_code":999,"name_similarity":1000,"definition_similarity":1001,"vector_similarity":1002,"score":1003},4326,"整形外科用カリパ","35788000",0.268293,0.187192,0.639364,0.0266667,{"medical_device_id":1005,"generic_name":1006,"class_classification":958,"jmdn_code":1007,"name_similarity":1008,"definition_similarity":1009,"vector_similarity":1010,"score":1011},2321,"整形外科用洗浄器","37026000",0.244444,0.244275,0.640754,0.0263889,{"medical_device_id":1013,"generic_name":1014,"class_classification":949,"jmdn_code":1015,"name_similarity":976,"definition_similarity":1016,"vector_similarity":1017,"score":1018},4328,"整形外科用やすり","36167001",0.0952381,0.631901,0.0253265,{"medical_device_id":1020,"generic_name":1021,"class_classification":958,"jmdn_code":1022,"name_similarity":1023,"definition_similarity":1024,"vector_similarity":1025,"score":1026},2891,"単回使用整形外科用バー","36249002",0.255319,0.158491,0.636999,0.0251821,[1028,1032,1036,1040,1044,1048,1051,1054,1057,1061,1065,1068],{"product_code":1029,"device_name":1030,"device_class":8,"k510_count":1031},"HAW","Neurological Stereotaxic Instrument",424,{"product_code":1033,"device_name":1034,"device_class":8,"k510_count":1035},"SBF","Orthopedic Augmented Reality",43,{"product_code":1037,"device_name":1038,"device_class":8,"k510_count":1039},"PGW","Ear, Nose, And Throat Stereotaxic Instrument",37,{"product_code":1041,"device_name":1042,"device_class":8,"k510_count":1043},"ONN","Intraoperative Orthopedic Joint Assessment Aid",18,{"product_code":1045,"device_name":1046,"device_class":8,"k510_count":1047},"OEW","Tracking, Soft Tissue, Intraoperative",4,{"product_code":1049,"device_name":1050,"device_class":8,"k510_count":1047},"OJP","Orthopedic Computer Controlled Surgical System",{"product_code":1052,"device_name":1053,"device_class":8,"k510_count":1047},"ONA","Computer Assisted Hair Harvesting System",{"product_code":1055,"device_name":1056,"device_class":8,"k510_count":1047},"ORR","Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri",{"product_code":1058,"device_name":1059,"device_class":8,"k510_count":1060},"OSF","Patient Specific Manual Orthopedic Stereotaxic System",3,{"product_code":1062,"device_name":1063,"device_class":8,"k510_count":1064},"QRI","Surgical Planning Software For Neurological Stereotaxic Instruments",1,{"product_code":1066,"device_name":1067,"device_class":8,"k510_count":1064},"SGE","Extracranial Positional System For A Transcranial Magnetic Stimulation System",{"product_code":1069,"device_name":1070,"device_class":8,"k510_count":942},"OSE","Patient Specific Manual Navigation System",{"510k":1072,"classification":1073,"enforcement":1074,"event":1075,"pma":1076,"warning_letter":1077},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]