[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HXZ":3},{"classification":4,"mappedDevices":372,"similarCandidates":373,"relatedClassifications":446,"syncDates":588},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":366,"updated_at":367,"recall_count":368,"latest_recall_date":369,"k510_count":368,"pma_count":370,"event_count":371},6062,"HXZ","Cutter, Wire","1","888.4540","OR","Orthopedic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":364,"product_code":6,"review_panel":10,"gmp_exempt_flag":364,"third_party_flag":364,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":364,"medical_specialty_description":11,"summary_malfunction_reporting":365},{"k_number":17,"fei_number":19,"registration_number":269},[18],"K873715",[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],"3374","3013540005","3042248499","3000321209","3006513362","2027754","1000199976","3003244954","3018094310","3022862651","3008534770","3012447612","3001084743","3002809532","3004545991","3005677016","1828464","3002807072","3002675176","3002808360","3003120897","3006846753","3004574120","3014615697","3042285592","3019455","3004892425","3003772581","3003052153","3003694247","3014257776","3012267976","3003431869","2523865","3003526896","3002929183","3015895045","1317628","3014201171","1000508235","3010303097","3004992978","3031261833","1000405819","1720747","3010829427","3002834291","3012501675","3008808049","3010646402","3016050940","3005973280","1526439","1923569","3005641619","3010235355","3007137643","3012995405","1000220733","3009417901","3016894896","3002750084","3007803626","3008770252","3014938863","3006554912","3004571672","3005061536","3007648354","3009790163","1818910","3002806685","3000183921","3005695838","1000136191","3002902165","3004111573","3004051158","3025380425","3038503932","3002786339","3003882387","3011371465","3008583793","1000160162","3012120772","3005897698","3009513193","3017521423","3003644849","3031564283","3002807682","3006891796","3003697160","3006444232","3004216008","3002807421","3042172872","3002806773","3005225959","1000512168","3005273623","3002806315","3001236905","3002807988","6507","5870","3010034765","3008812560","3004608878","3010687973","3026311512","3004504812","3016443334","3007284437","3008782585","3032747418","3002862271","3035678069","3005969827","3001026312","3014683120","3009468807","3010041511","3010097171","3003944071","1000159990","3000280067","1000453845","3004784004","1000208866","3015876273","1000272060","3021666757","3014334038","3005813597","3000219976","3005751028","1000124817","1032347","3004369356","3006509795","3002808335","3036795921","2080222","3031240334","3005304066","3005440795","3007282753","3006059835","3005528784","1417592","3013846070","3008599177","1219518","3005621335","1000525271","1000518604","3004001706","3005809810","1000402972","3009340886","1833053","2434839","3002806862","3008338766","3013011598","3546","3013946322","3010065126","3012103978","3034688516","3033536312","3013031133","3004530184","1000115331","3000327445","3002808043","3004464325","3000207350","3010455030","1824199","1825034","3010699884","3038195984","3029082594","3015487912","3002808003","1000111204","3007441485","4498","3002806816","3001236812","3002807395","3010509633","1219655","1020279","3008837339","3000204191","3003418325","3008455034","3002315844","5906","3004215117","3002807183","3002854251","3002807373","3002807214","3009703496","3008205331","3003386935","3007290840","3027556548","3006460162","1421101","3005083075","3006742481","3015515018","1000477302","3003128516","3003499455","2936485","1000119305","3001417518","3008237824","3007125392","3002807264","3003322138","3002807464","2916714","3002808293","3003914946","1000306694","3004049923","3007751820","7282","1000115048","3003969055","3016965929","2126670","3002902735","3035708926","3006272282","3034676720","3002807169","3005747797","1000390051","1000140363","3022748632",[270,21,22,24,25,271,27,272,28,273,29,30,31,32,274,41,35,36,40,38,43,44,45,275,276,277,278,46,49,50,279,280,51,281,282,283,52,54,56,58,284,285,60,61,62,64,65,66,67,68,69,70,71,72,73,286,75,74,77,287,76,79,288,80,83,84,289,85,290,291,86,292,293,88,89,90,87,294,295,93,296,297,98,96,99,101,298,102,103,299,300,105,106,107,108,301,109,110,302,303,304,112,305,306,114,307,308,117,309,310,311,121,119,312,128,129,130,131,132,133,134,136,137,138,141,142,143,144,313,149,314,151,315,153,154,155,156,316,157,317,159,318,319,320,321,163,164,322,323,165,167,324,325,326,169,327,170,328,172,171,174,329,175,178,179,330,331,332,181,333,182,183,185,334,186,335,336,337,338,188,189,190,339,191,192,193,194,196,340,341,198,200,201,342,202,203,204,343,206,205,344,209,345,346,347,214,215,216,217,219,220,222,223,228,348,349,232,233,350,234,236,351,237,235,352,353,354,241,245,247,249,355,356,253,357,254,358,257,359,360,258,259,262,261,263,361,362,363,268],"2031917","2084346","9611281","9610809","8010379","8010099","8010528","1835998","8010257","9614062","3004371426","9611367","9680059","1822565","9616088","9616246","1057946","9680515","8010733","8043971","9610612","2031009","8010235","1056350","3007507973","1055890","2087382","9611503","9613926","1932180","9611610","8010769","9681540","9611458","3007366790","9680411","3008812251","8040278","9611274","9710524","9680260","2132732","2431166","2085947","2531195","3004549189","9611827","1226544","9613079","3004774118","8010732","9680718","9613910","1313525","8010159","1836161","8010839","9616250","9613083","9612278","9616671","3011137372","9611283","1061124","8040884","9680619","9610905","9680518","8010250","9611062","8010372","9680002","1421879","1833824","8043496","8010665","8040233","1646747","2249529","1422507","1423537","8043622","2529846","9681622","8010168","9611390","1030489","8030607","9611813","2248030","9611112","3005067367","9612074","1424478","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-19T02:30:42.714273+00:00",1,"2020-12-30",0,510,[],[374,381,389,397,404,411,418,425,432,439],{"medical_device_id":375,"generic_name":376,"class_classification":377,"jmdn_code":378,"name_similarity":368,"definition_similarity":370,"vector_similarity":379,"score":380},4211,"ワイヤカッタ","Ⅰ","32885000",0.82555,0.0327869,{"medical_device_id":382,"generic_name":383,"class_classification":384,"jmdn_code":385,"name_similarity":386,"definition_similarity":370,"vector_similarity":387,"score":388},475,"結さつ線","Ⅲ","14457000",0.25,0.705434,0.0310544,{"medical_device_id":390,"generic_name":391,"class_classification":392,"jmdn_code":393,"name_similarity":394,"definition_similarity":370,"vector_similarity":395,"score":396},2839,"骨カッタ","Ⅱ","10455000",0.411765,0.658909,0.0308349,{"medical_device_id":398,"generic_name":399,"class_classification":377,"jmdn_code":400,"name_similarity":401,"definition_similarity":370,"vector_similarity":402,"score":403},4319,"ワイヤクリンパ","32879000",0.388889,0.660784,0.0307984,{"medical_device_id":405,"generic_name":406,"class_classification":377,"jmdn_code":407,"name_similarity":408,"definition_similarity":370,"vector_similarity":409,"score":410},3765,"ワイヤ・結さつ糸パサー","32864001",0.230769,0.681454,0.0303309,{"medical_device_id":412,"generic_name":413,"class_classification":377,"jmdn_code":414,"name_similarity":415,"definition_similarity":370,"vector_similarity":416,"score":417},3664,"血管内弁カッタ付カテーテル","70299000",0.219512,0.664797,0.0296443,{"medical_device_id":419,"generic_name":420,"class_classification":377,"jmdn_code":421,"name_similarity":422,"definition_similarity":370,"vector_similarity":423,"score":424},4192,"電動式ギプスカッタ","16340000",0.291667,0.652039,0.0294372,{"medical_device_id":426,"generic_name":427,"class_classification":377,"jmdn_code":428,"name_similarity":429,"definition_similarity":370,"vector_similarity":430,"score":431},4213,"つち骨カッタ","35213000",0.35,0.635128,0.0291385,{"medical_device_id":433,"generic_name":434,"class_classification":392,"jmdn_code":435,"name_similarity":436,"definition_similarity":370,"vector_similarity":437,"score":438},2562,"硝子体切除ユニットカッタハンドピース","34125000",0.184211,0.670019,0.0288981,{"medical_device_id":440,"generic_name":441,"class_classification":392,"jmdn_code":442,"name_similarity":443,"definition_similarity":370,"vector_similarity":444,"score":445},2221,"単回使用ワイヤ・結さつ糸パサー","32864002",0.162162,0.694346,0.0286935,[447,451,455,459,463,467,470,474,478,482,485,489,492,495,498,501,505,508,511,514,517,520,523,527,530,533,536,540,543,546,549,552,555,558,561,564,567,570,573,576,579,582,585],{"product_code":448,"device_name":449,"device_class":8,"k510_count":450},"LXH","Orthopedic Manual Surgical Instrument",58,{"product_code":452,"device_name":453,"device_class":8,"k510_count":454},"HXB","Probe",15,{"product_code":456,"device_name":457,"device_class":8,"k510_count":458},"HTO","Reamer",14,{"product_code":460,"device_name":461,"device_class":8,"k510_count":462},"HTW","Bit, Drill",11,{"product_code":464,"device_name":465,"device_class":8,"k510_count":466},"HTS","Knife, Orthopedic",9,{"product_code":468,"device_name":469,"device_class":8,"k510_count":466},"HWQ","Passer",{"product_code":471,"device_name":472,"device_class":8,"k510_count":473},"HRR","Scissors, Orthopedic, Surgical",8,{"product_code":475,"device_name":476,"device_class":8,"k510_count":477},"HXY","Brace, Drill",7,{"product_code":479,"device_name":480,"device_class":8,"k510_count":481},"HXC","Wrench",6,{"product_code":483,"device_name":484,"device_class":8,"k510_count":481},"HXJ","Staple Driver",{"product_code":486,"device_name":487,"device_class":8,"k510_count":488},"HTP","File",5,{"product_code":490,"device_name":491,"device_class":8,"k510_count":488},"HTX","Rongeur",{"product_code":493,"device_name":494,"device_class":8,"k510_count":488},"HWB","Extractor",{"product_code":496,"device_name":497,"device_class":8,"k510_count":488},"HXK","Holder, Needle; Orthopedic",{"product_code":499,"device_name":500,"device_class":8,"k510_count":488},"HXP","Instrument, Bending Or Contouring",{"product_code":502,"device_name":503,"device_class":8,"k510_count":504},"HTT","Burr, Orthopedic",4,{"product_code":506,"device_name":507,"device_class":8,"k510_count":504},"HWA","Impactor",{"product_code":509,"device_name":510,"device_class":8,"k510_count":504},"HWJ","Awl",{"product_code":512,"device_name":513,"device_class":8,"k510_count":504},"HWN","Instrument, Compression",{"product_code":515,"device_name":516,"device_class":8,"k510_count":504},"HWR","Driver, Prosthesis",{"product_code":518,"device_name":519,"device_class":8,"k510_count":504},"HXX","Screwdriver",{"product_code":521,"device_name":522,"device_class":8,"k510_count":504},"LYS","Bone Mill",{"product_code":524,"device_name":525,"device_class":8,"k510_count":526},"HXI","Passer, Wire, Orthopedic",3,{"product_code":528,"device_name":529,"device_class":8,"k510_count":526},"HXO","Pusher, Socket",{"product_code":531,"device_name":532,"device_class":8,"k510_count":526},"HXW","Bender",{"product_code":534,"device_name":535,"device_class":8,"k510_count":526},"LYQ","Accessories, Fixation, Spinal Intervertebral Body",{"product_code":537,"device_name":538,"device_class":8,"k510_count":539},"HWX","Tap, Bone",2,{"product_code":541,"device_name":542,"device_class":8,"k510_count":539},"HXN","Applier, Cerclage",{"product_code":544,"device_name":545,"device_class":8,"k510_count":539},"HXS","Twister, Wire",{"product_code":547,"device_name":548,"device_class":8,"k510_count":368},"HWI","Corkscrew",{"product_code":550,"device_name":551,"device_class":8,"k510_count":368},"HWK","Trephine",{"product_code":553,"device_name":554,"device_class":8,"k510_count":368},"HWP","Punch, Femoral Neck",{"product_code":556,"device_name":557,"device_class":8,"k510_count":368},"HXG","Tamp",{"product_code":559,"device_name":560,"device_class":8,"k510_count":368},"KIL","Positioner, Socket",{"product_code":562,"device_name":563,"device_class":8,"k510_count":368},"OCJ","Spinal Channeling Instrument, Vertebroplasty",{"product_code":565,"device_name":566,"device_class":8,"k510_count":370},"HRT","Stripper, Surgical",{"product_code":568,"device_name":569,"device_class":8,"k510_count":370},"HTQ","Broach",{"product_code":571,"device_name":572,"device_class":8,"k510_count":370},"HWD","Starter, Bone Screw",{"product_code":574,"device_name":575,"device_class":8,"k510_count":370},"HWL","Set, Hollow Mill",{"product_code":577,"device_name":578,"device_class":8,"k510_count":370},"HWO","Skid, Bone",{"product_code":580,"device_name":581,"device_class":8,"k510_count":370},"HWW","Countersink",{"product_code":583,"device_name":584,"device_class":8,"k510_count":370},"HXE","Fork",{"product_code":586,"device_name":587,"device_class":8,"k510_count":370},"HXQ","Crimper, Pin",{"510k":589,"classification":590,"enforcement":591,"event":592,"pma":593,"warning_letter":594},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]