[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HTP":3},{"classification":4,"mappedDevices":134,"similarCandidates":135,"relatedClassifications":207,"syncDates":347},{"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":128,"updated_at":129,"recall_count":130,"latest_recall_date":131,"k510_count":132,"pma_count":130,"event_count":133},2417,"HTP","File","1","888.4540","OR","Orthopedic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":126,"product_code":6,"review_panel":10,"gmp_exempt_flag":126,"third_party_flag":126,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":126,"medical_specialty_description":11,"summary_malfunction_reporting":127},{"k_number":17,"fei_number":23,"registration_number":101},[18,19,20,21,22],"K840492","K841981","K931733","K862659","K870842",[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],"3004824601","2027754","1000199976","3016438694","3003424264","3010536692","3006846753","3002675176","3010595915","3004574120","3030514683","3004028763","3038187464","3011513267","3015516266","3010303097","3011683674","3004095748","3009756153","3012130008","3002750084","3007311878","3020155054","3008770252","3009790163","1818910","3002786339","3003882387","3009702671","3009513193","3003697160","3005747797","3002806773","3005273623","3002806315","5870","3013875765","3016443334","3010041511","3003944071","1000272060","3021666757","3014334038","1412854","4476","3006509795","3004905643","3005440795","3005528784","3013846070","3009973505","3035366890","3005809810","1038671","3546","3033536312","1825034","3010699884","3015487912","1219655","3003418325","3004215117","3002854251","3002807214","3006460162","1421101","3009973844","3003499455","3015542154","2916714","3012725451","1000116912","1000115048","3002808264","3035708926","3015207155","3004216008",[24,25,27,29,102,30,31,32,34,103,104,105,36,37,38,39,40,42,43,45,46,47,106,107,48,49,108,51,52,53,109,110,57,60,61,62,65,66,67,111,112,70,71,113,72,73,74,75,114,76,115,116,77,79,117,80,81,82,118,83,84,85,119,88,89,90,92,93,94,120,121,98,122,123,99,124,125],"8010379","9614986","9611278","8010099","9610612","8043971","2087382","8040278","9710524","9613079","9613910","1836161","8010155","9616671","3011137372","1421879","8040233","2249529","9611390","8030607","3005067367","1644408","9680735","8044098","N","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,9,[],[136,144,152,159,166,173,180,186,193,200],{"medical_device_id":137,"generic_name":138,"class_classification":139,"jmdn_code":140,"name_similarity":141,"definition_similarity":130,"vector_similarity":142,"score":143},4196,"やすり","Ⅰ","11701001",1,0.75475,0.0327869,{"medical_device_id":145,"generic_name":146,"class_classification":147,"jmdn_code":148,"name_similarity":149,"definition_similarity":130,"vector_similarity":150,"score":151},2851,"単回使用やすり","Ⅱ","11701002",0.333333,0.68231,0.032002,{"medical_device_id":153,"generic_name":154,"class_classification":147,"jmdn_code":155,"name_similarity":156,"definition_similarity":130,"vector_similarity":157,"score":158},2577,"電動式歯科用ファイル","31878022",0.25,0.648088,0.0310245,{"medical_device_id":160,"generic_name":161,"class_classification":139,"jmdn_code":162,"name_similarity":163,"definition_similarity":130,"vector_similarity":164,"score":165},4328,"整形外科用やすり","36167001",0.3125,0.626759,0.0310096,{"medical_device_id":167,"generic_name":168,"class_classification":139,"jmdn_code":169,"name_similarity":170,"definition_similarity":130,"vector_similarity":171,"score":172},4197,"歯科用辺縁仕上げファイル","31863000",0.185185,0.611119,0.0294372,{"medical_device_id":174,"generic_name":175,"class_classification":147,"jmdn_code":176,"name_similarity":177,"definition_similarity":130,"vector_similarity":178,"score":179},2576,"単回使用歯科用ファイル","31878012",0.227273,0.588746,0.0294181,{"medical_device_id":181,"generic_name":182,"class_classification":147,"jmdn_code":183,"name_similarity":184,"definition_similarity":130,"vector_similarity":185,"score":179},2889,"単回使用整形外科用やすり","36167002",0.192308,0.601874,{"medical_device_id":187,"generic_name":188,"class_classification":139,"jmdn_code":189,"name_similarity":190,"definition_similarity":130,"vector_similarity":191,"score":192},4199,"歯科練成充填材用ファイル","37629000",0.151515,0.642923,0.0287829,{"medical_device_id":194,"generic_name":195,"class_classification":139,"jmdn_code":196,"name_similarity":197,"definition_similarity":130,"vector_similarity":198,"score":199},4027,"歯科用ファイルラスプ","31878011",0.294118,0.551725,0.0285425,{"medical_device_id":201,"generic_name":202,"class_classification":139,"jmdn_code":203,"name_similarity":204,"definition_similarity":130,"vector_similarity":205,"score":206},4028,"歯科用ファイル","31878021",0.416667,0.526533,0.016129,[208,212,216,220,224,227,230,234,238,242,245,248,251,254,257,261,264,267,270,273,276,279,283,286,289,292,296,299,302,305,308,311,314,317,320,323,326,329,332,335,338,341,344],{"product_code":209,"device_name":210,"device_class":8,"k510_count":211},"LXH","Orthopedic Manual Surgical Instrument",58,{"product_code":213,"device_name":214,"device_class":8,"k510_count":215},"HXB","Probe",15,{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"HTO","Reamer",14,{"product_code":221,"device_name":222,"device_class":8,"k510_count":223},"HTW","Bit, Drill",11,{"product_code":225,"device_name":226,"device_class":8,"k510_count":133},"HTS","Knife, Orthopedic",{"product_code":228,"device_name":229,"device_class":8,"k510_count":133},"HWQ","Passer",{"product_code":231,"device_name":232,"device_class":8,"k510_count":233},"HRR","Scissors, Orthopedic, Surgical",8,{"product_code":235,"device_name":236,"device_class":8,"k510_count":237},"HXY","Brace, Drill",7,{"product_code":239,"device_name":240,"device_class":8,"k510_count":241},"HXC","Wrench",6,{"product_code":243,"device_name":244,"device_class":8,"k510_count":241},"HXJ","Staple Driver",{"product_code":246,"device_name":247,"device_class":8,"k510_count":132},"HTX","Rongeur",{"product_code":249,"device_name":250,"device_class":8,"k510_count":132},"HWB","Extractor",{"product_code":252,"device_name":253,"device_class":8,"k510_count":132},"HXK","Holder, Needle; Orthopedic",{"product_code":255,"device_name":256,"device_class":8,"k510_count":132},"HXP","Instrument, Bending Or Contouring",{"product_code":258,"device_name":259,"device_class":8,"k510_count":260},"HTT","Burr, Orthopedic",4,{"product_code":262,"device_name":263,"device_class":8,"k510_count":260},"HWA","Impactor",{"product_code":265,"device_name":266,"device_class":8,"k510_count":260},"HWJ","Awl",{"product_code":268,"device_name":269,"device_class":8,"k510_count":260},"HWN","Instrument, Compression",{"product_code":271,"device_name":272,"device_class":8,"k510_count":260},"HWR","Driver, Prosthesis",{"product_code":274,"device_name":275,"device_class":8,"k510_count":260},"HXX","Screwdriver",{"product_code":277,"device_name":278,"device_class":8,"k510_count":260},"LYS","Bone Mill",{"product_code":280,"device_name":281,"device_class":8,"k510_count":282},"HXI","Passer, Wire, Orthopedic",3,{"product_code":284,"device_name":285,"device_class":8,"k510_count":282},"HXO","Pusher, Socket",{"product_code":287,"device_name":288,"device_class":8,"k510_count":282},"HXW","Bender",{"product_code":290,"device_name":291,"device_class":8,"k510_count":282},"LYQ","Accessories, Fixation, Spinal Intervertebral Body",{"product_code":293,"device_name":294,"device_class":8,"k510_count":295},"HWX","Tap, Bone",2,{"product_code":297,"device_name":298,"device_class":8,"k510_count":295},"HXN","Applier, Cerclage",{"product_code":300,"device_name":301,"device_class":8,"k510_count":295},"HXS","Twister, Wire",{"product_code":303,"device_name":304,"device_class":8,"k510_count":141},"HWI","Corkscrew",{"product_code":306,"device_name":307,"device_class":8,"k510_count":141},"HWK","Trephine",{"product_code":309,"device_name":310,"device_class":8,"k510_count":141},"HWP","Punch, Femoral Neck",{"product_code":312,"device_name":313,"device_class":8,"k510_count":141},"HXG","Tamp",{"product_code":315,"device_name":316,"device_class":8,"k510_count":141},"HXZ","Cutter, Wire",{"product_code":318,"device_name":319,"device_class":8,"k510_count":141},"KIL","Positioner, Socket",{"product_code":321,"device_name":322,"device_class":8,"k510_count":141},"OCJ","Spinal Channeling Instrument, Vertebroplasty",{"product_code":324,"device_name":325,"device_class":8,"k510_count":130},"HRT","Stripper, Surgical",{"product_code":327,"device_name":328,"device_class":8,"k510_count":130},"HTQ","Broach",{"product_code":330,"device_name":331,"device_class":8,"k510_count":130},"HWD","Starter, Bone Screw",{"product_code":333,"device_name":334,"device_class":8,"k510_count":130},"HWL","Set, Hollow Mill",{"product_code":336,"device_name":337,"device_class":8,"k510_count":130},"HWO","Skid, Bone",{"product_code":339,"device_name":340,"device_class":8,"k510_count":130},"HWW","Countersink",{"product_code":342,"device_name":343,"device_class":8,"k510_count":130},"HXE","Fork",{"product_code":345,"device_name":346,"device_class":8,"k510_count":130},"HXQ","Crimper, Pin",{"510k":348,"classification":349,"enforcement":350,"event":351,"pma":352,"warning_letter":353},"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"]