[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HTS":3},{"classification":4,"mappedDevices":203,"similarCandidates":204,"relatedClassifications":277,"syncDates":418},{"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":196,"updated_at":197,"recall_count":198,"latest_recall_date":199,"k510_count":200,"pma_count":201,"event_count":202},6848,"HTS","Knife, Orthopedic","1","888.4540","OR","Orthopedic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":194,"product_code":6,"review_panel":10,"gmp_exempt_flag":194,"third_party_flag":194,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":194,"medical_specialty_description":11,"summary_malfunction_reporting":195},{"k_number":17,"fei_number":27,"registration_number":146},[18,19,20,21,22,23,24,25,26],"K873714","K933921","K873713","K873711","K882525","K873712","K930507","K842820","K771851",[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],"1526534","1000199976","3018094310","3003424264","3010536692","3013421458","1828464","3003120897","3002808360","1211998","3004574120","3030514683","3004028763","1000120768","3005734757","3009189869","3018821071","2523865","3002929183","3015895045","3010303097","3009756153","3015167917","3007887711","1720747","3012130008","1923569","3005641619","1526439","1017294","1000220733","3002750084","3002299608","3008770252","1000219637","3008936260","3005061536","3009790163","1000136191","3015259876","3002786339","3009702671","3009513193","3013466775","3002808001","3004216008","3005273623","3002806315","5870","3004608878","3008782585","1220477","3015176311","3010097171","3010041511","3000280067","3003944071","1000272060","3014334038","3005751028","2027467","4476","3006509795","3021519357","3005304066","3005440795","3005528784","3008076203","3013846070","1417592","3008599177","3005809810","3039103971","1000402972","3002806862","3002631673","3546","3002806452","3033536312","3008114965","3003435550","3002808043","3004464325","3010455030","1824199","3007714917","3002806816","3023657851","3008837339","3003418325","1416666","3002809480","1421101","3003407244","3002807754","1000477302","3003499455","2936485","3001417518","3021948057","3003696170","2916714","3042508254","3003914946","3019878714","3007327603","7282","1000115048","1000136478","3002808264","1221934","3013497507","3006639700","1218017","3027262786","3002807328","3011024991","3005747797",[147,28,30,148,32,33,149,34,35,37,39,150,151,152,153,43,44,154,47,48,49,50,51,52,53,54,55,56,57,155,61,156,157,63,64,65,67,158,69,70,159,71,160,161,162,74,163,164,77,79,165,80,81,82,86,87,88,166,167,91,168,169,93,170,94,95,171,96,97,172,173,99,174,100,175,176,177,106,107,108,110,111,112,178,179,180,115,181,116,117,118,182,183,120,184,121,185,186,125,127,128,129,187,130,132,188,133,189,190,138,139,140,141,191,142,192,144,193],"2031917","8043441","8010379","9614986","9611278","8010099","9680059","1822565","8010733","9610612","8043971","9613926","8010769","8040278","9611274","9710524","1222773","2431166","1058584","3004774118","9680718","9612075","9613910","1836161","9613083","9612278","8010155","8043816","9611283","3011137372","9680518","1421879","8010704","8040233","3032391","2249529","1319660","2529846","8040179","9680519","1030489","9612277","8030607","9611112","9611102","3005067367","8044098","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",3,"2022-11-16",9,0,12,[],[205,213,220,227,235,242,249,256,263,270],{"medical_device_id":206,"generic_name":207,"class_classification":208,"jmdn_code":209,"name_similarity":210,"definition_similarity":201,"vector_similarity":211,"score":212},4328,"整形外科用やすり","Ⅰ","36167001",0.5,0.719269,0.031498,{"medical_device_id":214,"generic_name":215,"class_classification":208,"jmdn_code":216,"name_similarity":217,"definition_similarity":201,"vector_similarity":218,"score":219},4180,"メス","35130001",0.352941,0.738243,0.030478,{"medical_device_id":221,"generic_name":222,"class_classification":208,"jmdn_code":223,"name_similarity":224,"definition_similarity":201,"vector_similarity":225,"score":226},4173,"骨刀","12844000",0.423077,0.703431,0.0298507,{"medical_device_id":228,"generic_name":229,"class_classification":230,"jmdn_code":231,"name_similarity":232,"definition_similarity":201,"vector_similarity":233,"score":234},2889,"単回使用整形外科用やすり","Ⅱ","36167002",0.34375,0.724801,0.0295716,{"medical_device_id":236,"generic_name":237,"class_classification":208,"jmdn_code":238,"name_similarity":239,"definition_similarity":201,"vector_similarity":240,"score":241},4306,"整形外科用リーマ","35297001",0.458333,0.684985,0.0293236,{"medical_device_id":243,"generic_name":244,"class_classification":208,"jmdn_code":245,"name_similarity":246,"definition_similarity":201,"vector_similarity":247,"score":248},4330,"整形外科用バー","36249001",0.52381,0.670802,0.0290517,{"medical_device_id":250,"generic_name":251,"class_classification":208,"jmdn_code":252,"name_similarity":253,"definition_similarity":201,"vector_similarity":254,"score":255},4342,"整形外科用固定鉗子","42894000",0.333333,0.70789,0.0284848,{"medical_device_id":257,"generic_name":258,"class_classification":208,"jmdn_code":259,"name_similarity":260,"definition_similarity":201,"vector_similarity":261,"score":262},4172,"ナイフハンドル","12235000",0.25,0.729965,0.0274927,{"medical_device_id":264,"generic_name":265,"class_classification":208,"jmdn_code":266,"name_similarity":267,"definition_similarity":201,"vector_similarity":268,"score":269},4170,"耳用ナイフ","12245000",0.285714,0.696757,0.0266314,{"medical_device_id":271,"generic_name":272,"class_classification":208,"jmdn_code":273,"name_similarity":274,"definition_similarity":201,"vector_similarity":275,"score":276},4178,"眼科用ナイフ","32764001",0.307692,0.684677,0.0260135,[278,282,286,290,294,297,301,305,309,312,316,319,322,325,328,332,335,338,341,344,347,350,353,356,359,362,366,369,372,376,379,382,385,388,391,394,397,400,403,406,409,412,415],{"product_code":279,"device_name":280,"device_class":8,"k510_count":281},"LXH","Orthopedic Manual Surgical Instrument",58,{"product_code":283,"device_name":284,"device_class":8,"k510_count":285},"HXB","Probe",15,{"product_code":287,"device_name":288,"device_class":8,"k510_count":289},"HTO","Reamer",14,{"product_code":291,"device_name":292,"device_class":8,"k510_count":293},"HTW","Bit, Drill",11,{"product_code":295,"device_name":296,"device_class":8,"k510_count":200},"HWQ","Passer",{"product_code":298,"device_name":299,"device_class":8,"k510_count":300},"HRR","Scissors, Orthopedic, Surgical",8,{"product_code":302,"device_name":303,"device_class":8,"k510_count":304},"HXY","Brace, Drill",7,{"product_code":306,"device_name":307,"device_class":8,"k510_count":308},"HXC","Wrench",6,{"product_code":310,"device_name":311,"device_class":8,"k510_count":308},"HXJ","Staple Driver",{"product_code":313,"device_name":314,"device_class":8,"k510_count":315},"HTP","File",5,{"product_code":317,"device_name":318,"device_class":8,"k510_count":315},"HTX","Rongeur",{"product_code":320,"device_name":321,"device_class":8,"k510_count":315},"HWB","Extractor",{"product_code":323,"device_name":324,"device_class":8,"k510_count":315},"HXK","Holder, Needle; Orthopedic",{"product_code":326,"device_name":327,"device_class":8,"k510_count":315},"HXP","Instrument, Bending Or Contouring",{"product_code":329,"device_name":330,"device_class":8,"k510_count":331},"HTT","Burr, Orthopedic",4,{"product_code":333,"device_name":334,"device_class":8,"k510_count":331},"HWA","Impactor",{"product_code":336,"device_name":337,"device_class":8,"k510_count":331},"HWJ","Awl",{"product_code":339,"device_name":340,"device_class":8,"k510_count":331},"HWN","Instrument, Compression",{"product_code":342,"device_name":343,"device_class":8,"k510_count":331},"HWR","Driver, Prosthesis",{"product_code":345,"device_name":346,"device_class":8,"k510_count":331},"HXX","Screwdriver",{"product_code":348,"device_name":349,"device_class":8,"k510_count":331},"LYS","Bone Mill",{"product_code":351,"device_name":352,"device_class":8,"k510_count":198},"HXI","Passer, Wire, Orthopedic",{"product_code":354,"device_name":355,"device_class":8,"k510_count":198},"HXO","Pusher, Socket",{"product_code":357,"device_name":358,"device_class":8,"k510_count":198},"HXW","Bender",{"product_code":360,"device_name":361,"device_class":8,"k510_count":198},"LYQ","Accessories, Fixation, Spinal Intervertebral Body",{"product_code":363,"device_name":364,"device_class":8,"k510_count":365},"HWX","Tap, Bone",2,{"product_code":367,"device_name":368,"device_class":8,"k510_count":365},"HXN","Applier, Cerclage",{"product_code":370,"device_name":371,"device_class":8,"k510_count":365},"HXS","Twister, Wire",{"product_code":373,"device_name":374,"device_class":8,"k510_count":375},"HWI","Corkscrew",1,{"product_code":377,"device_name":378,"device_class":8,"k510_count":375},"HWK","Trephine",{"product_code":380,"device_name":381,"device_class":8,"k510_count":375},"HWP","Punch, Femoral Neck",{"product_code":383,"device_name":384,"device_class":8,"k510_count":375},"HXG","Tamp",{"product_code":386,"device_name":387,"device_class":8,"k510_count":375},"HXZ","Cutter, Wire",{"product_code":389,"device_name":390,"device_class":8,"k510_count":375},"KIL","Positioner, Socket",{"product_code":392,"device_name":393,"device_class":8,"k510_count":375},"OCJ","Spinal Channeling Instrument, Vertebroplasty",{"product_code":395,"device_name":396,"device_class":8,"k510_count":201},"HRT","Stripper, Surgical",{"product_code":398,"device_name":399,"device_class":8,"k510_count":201},"HTQ","Broach",{"product_code":401,"device_name":402,"device_class":8,"k510_count":201},"HWD","Starter, Bone Screw",{"product_code":404,"device_name":405,"device_class":8,"k510_count":201},"HWL","Set, Hollow Mill",{"product_code":407,"device_name":408,"device_class":8,"k510_count":201},"HWO","Skid, Bone",{"product_code":410,"device_name":411,"device_class":8,"k510_count":201},"HWW","Countersink",{"product_code":413,"device_name":414,"device_class":8,"k510_count":201},"HXE","Fork",{"product_code":416,"device_name":417,"device_class":8,"k510_count":201},"HXQ","Crimper, Pin",{"510k":419,"classification":420,"enforcement":421,"event":422,"pma":423,"warning_letter":424},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]