[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HWI":3},{"classification":4,"mappedDevices":75,"similarCandidates":76,"relatedClassifications":145,"syncDates":285,"translation":292,"marketSummary":298,"recalls":314,"k510s":316,"pmas":323},{"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":69,"updated_at":70,"recall_count":71,"latest_recall_date":72,"k510_count":73,"pma_count":71,"event_count":74},1099,"HWI","Corkscrew","1","888.4540","OR","Orthopedic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":67,"product_code":6,"review_panel":10,"gmp_exempt_flag":67,"third_party_flag":67,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":67,"medical_specialty_description":11,"summary_malfunction_reporting":68},{"k_number":17,"fei_number":19,"registration_number":56},[18],"K875166",[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],"3002750084","3008770252","1032347","3006509795","5906","3004215117","3002904345","3018094310","3005061536","3009790163","3005528784","1421101","1417592","3015259876","1828464","3003120897","1000477302","3009106092","1000518604","3008544874","2916714","3012267976","3004216008","3042508254","3002806315","3010034765","1000115048","3016443334","3029933740","3010303097","1825034","3015167917","1828288","3010041511","1923569","3005747797",[21,22,57,24,25,27,28,58,29,59,30,31,32,33,34,35,37,39,60,61,40,41,62,63,64,43,65,47,48,49,66,50,51,52,53,54],"9610612","3007507973","1836161","3011137372","1835998","8040278","1030489","9611579","8030607","1421879","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:49.029844+00:00",0,null,1,8,[],[77,85,92,99,107,113,119,126,132,139],{"medical_device_id":78,"generic_name":79,"class_classification":80,"jmdn_code":81,"name_similarity":82,"definition_similarity":71,"vector_similarity":83,"score":84},1090,"歯科矯正用アンカースクリュー","Ⅲ","46536003",0.129032,0.557407,0.0295716,{"medical_device_id":86,"generic_name":87,"class_classification":88,"jmdn_code":89,"name_similarity":71,"definition_similarity":71,"vector_similarity":90,"score":91},2634,"歯列矯正用ロック","Ⅱ","38741000",0.580017,0.0163934,{"medical_device_id":93,"generic_name":94,"class_classification":95,"jmdn_code":96,"name_similarity":97,"definition_similarity":71,"vector_similarity":98,"score":91},4304,"骨ネジスタータ","Ⅰ","32859000",0.166667,0.537293,{"medical_device_id":100,"generic_name":101,"class_classification":102,"jmdn_code":103,"name_similarity":104,"definition_similarity":71,"vector_similarity":105,"score":106},226,"冠動脈ステント","Ⅳ","36035004",0.136364,0.496663,0.016129,{"medical_device_id":108,"generic_name":109,"class_classification":102,"jmdn_code":110,"name_similarity":111,"definition_similarity":71,"vector_similarity":112,"score":106},1092,"冠動脈カテーテル交換用カテーテル","17846124",0.0697674,0.579254,{"medical_device_id":114,"generic_name":115,"class_classification":95,"jmdn_code":116,"name_similarity":71,"definition_similarity":71,"vector_similarity":117,"score":118},4353,"木製つち","11947020",0.575434,0.015873,{"medical_device_id":120,"generic_name":121,"class_classification":102,"jmdn_code":122,"name_similarity":123,"definition_similarity":71,"vector_similarity":124,"score":125},94,"心血管用カテーテルガイドワイヤ","70287009",0.0243902,0.571991,0.015625,{"medical_device_id":127,"generic_name":128,"class_classification":80,"jmdn_code":129,"name_similarity":130,"definition_similarity":71,"vector_similarity":131,"score":125},585,"体内固定用ネジ","16101003",0.121212,0.489013,{"medical_device_id":133,"generic_name":134,"class_classification":102,"jmdn_code":135,"name_similarity":136,"definition_similarity":71,"vector_similarity":137,"score":138},5,"皮質電極","32545000",0.115385,0.457109,0.0153846,{"medical_device_id":140,"generic_name":141,"class_classification":102,"jmdn_code":142,"name_similarity":143,"definition_similarity":71,"vector_similarity":144,"score":138},89,"中枢神経系用カテーテルガイドワイヤ","35094124",0.02,0.568523,[146,150,154,158,162,166,169,172,176,180,183,186,189,192,195,198,202,205,208,211,214,217,220,224,227,230,233,237,240,243,246,249,252,255,258,261,264,267,270,273,276,279,282],{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"LXH","Orthopedic Manual Surgical Instrument",58,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"HXB","Probe",15,{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"HTO","Reamer",14,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"HTW","Bit, Drill",11,{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"HTS","Knife, Orthopedic",9,{"product_code":167,"device_name":168,"device_class":8,"k510_count":165},"HWQ","Passer",{"product_code":170,"device_name":171,"device_class":8,"k510_count":74},"HRR","Scissors, Orthopedic, Surgical",{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"HXY","Brace, Drill",7,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"HXC","Wrench",6,{"product_code":181,"device_name":182,"device_class":8,"k510_count":179},"HXJ","Staple Driver",{"product_code":184,"device_name":185,"device_class":8,"k510_count":133},"HTP","File",{"product_code":187,"device_name":188,"device_class":8,"k510_count":133},"HTX","Rongeur",{"product_code":190,"device_name":191,"device_class":8,"k510_count":133},"HWB","Extractor",{"product_code":193,"device_name":194,"device_class":8,"k510_count":133},"HXK","Holder, Needle; Orthopedic",{"product_code":196,"device_name":197,"device_class":8,"k510_count":133},"HXP","Instrument, Bending Or Contouring",{"product_code":199,"device_name":200,"device_class":8,"k510_count":201},"HTT","Burr, Orthopedic",4,{"product_code":203,"device_name":204,"device_class":8,"k510_count":201},"HWA","Impactor",{"product_code":206,"device_name":207,"device_class":8,"k510_count":201},"HWJ","Awl",{"product_code":209,"device_name":210,"device_class":8,"k510_count":201},"HWN","Instrument, Compression",{"product_code":212,"device_name":213,"device_class":8,"k510_count":201},"HWR","Driver, Prosthesis",{"product_code":215,"device_name":216,"device_class":8,"k510_count":201},"HXX","Screwdriver",{"product_code":218,"device_name":219,"device_class":8,"k510_count":201},"LYS","Bone Mill",{"product_code":221,"device_name":222,"device_class":8,"k510_count":223},"HXI","Passer, Wire, Orthopedic",3,{"product_code":225,"device_name":226,"device_class":8,"k510_count":223},"HXO","Pusher, Socket",{"product_code":228,"device_name":229,"device_class":8,"k510_count":223},"HXW","Bender",{"product_code":231,"device_name":232,"device_class":8,"k510_count":223},"LYQ","Accessories, Fixation, Spinal Intervertebral Body",{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"HWX","Tap, Bone",2,{"product_code":238,"device_name":239,"device_class":8,"k510_count":236},"HXN","Applier, Cerclage",{"product_code":241,"device_name":242,"device_class":8,"k510_count":236},"HXS","Twister, Wire",{"product_code":244,"device_name":245,"device_class":8,"k510_count":73},"HWK","Trephine",{"product_code":247,"device_name":248,"device_class":8,"k510_count":73},"HWP","Punch, Femoral Neck",{"product_code":250,"device_name":251,"device_class":8,"k510_count":73},"HXG","Tamp",{"product_code":253,"device_name":254,"device_class":8,"k510_count":73},"HXZ","Cutter, Wire",{"product_code":256,"device_name":257,"device_class":8,"k510_count":73},"KIL","Positioner, Socket",{"product_code":259,"device_name":260,"device_class":8,"k510_count":73},"OCJ","Spinal Channeling Instrument, Vertebroplasty",{"product_code":262,"device_name":263,"device_class":8,"k510_count":71},"HRT","Stripper, Surgical",{"product_code":265,"device_name":266,"device_class":8,"k510_count":71},"HTQ","Broach",{"product_code":268,"device_name":269,"device_class":8,"k510_count":71},"HWD","Starter, Bone Screw",{"product_code":271,"device_name":272,"device_class":8,"k510_count":71},"HWL","Set, Hollow Mill",{"product_code":274,"device_name":275,"device_class":8,"k510_count":71},"HWO","Skid, Bone",{"product_code":277,"device_name":278,"device_class":8,"k510_count":71},"HWW","Countersink",{"product_code":280,"device_name":281,"device_class":8,"k510_count":71},"HXE","Fork",{"product_code":283,"device_name":284,"device_class":8,"k510_count":71},"HXQ","Crimper, Pin",{"510k":286,"classification":287,"enforcement":288,"event":289,"pma":290,"warning_letter":291},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":293,"definition_ja":72,"commentary_ja":294,"model_name":295,"source_hash":296,"reviewed_by":72,"reviewed_at":72,"created_at":297,"updated_at":297},"コークスクリュー型骨固定具","本品は整形外科領域で使用される、コークスクリュー状の形状を持つ骨固定用器具です。米国ではクラスIに分類されており、人体へのリスクが低いと判断される医療機器に位置づけられています。そのため市販前届出（510(k)）が免除されており、市販前承認（PMA）や510(k)による個別審査を経ることなく市場に流通させることが可能です。","claude-sonnet-5","1fb9f3bc0517607f11c123c186ebdf72fa45654dc8ef8c947b5ace1eadb86675","2026-08-24T01:58:54.742189+00:00",{"product_code":6,"summary_ja":299,"stats":300,"stats_hash":312,"model_name":295,"created_at":313,"updated_at":313},"Corkscrew（product code: HWI）は届出免除の対象であり、510(k)は累計1件が確認されているのみで、直近5年間の新規届出は確認されていません。不具合報告は累計約8件で、傷害と不具合（Malfunction）がそれぞれ約半数を占めており、死亡報告は0件です。主な問題としてはFracture \u002F Break（破損・破断）が挙げられています。回収については累計件数は確認されていません。",{"pma":301,"k510":302,"as_of":304,"events":305,"recalls":307,"top_problems":309},{"latest":72,"originals":71,"supplements":71},{"total":73,"last5y":71,"latest":303,"applicants":73},"1988-03-02","2026-08",{"death":71,"other":71,"total":74,"injury":201,"last5y":223,"malfunction":201,"latest_month":306},"2024-04",{"total":71,"last5y":71,"latest":72,"class_i":71,"class_ii":71,"class_iii":71,"top_root_causes":308},[],[310,311],"Fracture","Break","0441f772ed5c858af45bf26f0c95a43d6f554137b954a52fc0f2312c15aea336","2026-08-24T04:34:15.487438+00:00",{"items":315,"total":71},[],{"items":317,"total":73},[318],{"k_number":18,"device_name":319,"applicant":320,"decision_date":303,"clearance_type":321,"decision_code":322,"statement_or_summary":72},"PHARMASEAL STERILE UMBILICAL CORD CLAMP","Baxter Healthcare Corp","Traditional","SESE",{"items":324,"total":71},[]]