[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OSF":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":118,"syncDates":161},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":34,"event_count":34},6079,"OSF","Patient Specific Manual Orthopedic Stereotaxic System","2","882.4560","NE","Neurology","OR","1","Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":12,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":26,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":18,"fei_number":22,"registration_number":25},[19,20,21],"K093491","K200384","K233315",[23,24],"3008869747","3016676864",[23,24],"","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",1,"2015-11-04",3,0,[],[37,46,55,64,72,80,88,96,103,111],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},1053,"整形外科用脊椎外固定システム","Ⅲ","42848000",0.323529,0.135638,0.722828,0.0325225,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},4307,"手動式整形外科用セメントディスペンサ","Ⅰ","35809001",0.333333,0.168675,0.654939,0.0278877,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},2880,"手動式整形外科用注入器","Ⅱ","70956000",0.25,0.148718,0.661333,0.0276929,{"medical_device_id":65,"generic_name":66,"class_classification":49,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},4306,"整形外科用リーマ","35297001",0.196429,0.164773,0.667474,0.0257468,{"medical_device_id":73,"generic_name":74,"class_classification":49,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},3870,"整形外科用手術台","35394000",0.193548,0.156379,0.658048,0.0235327,{"medical_device_id":81,"generic_name":82,"class_classification":40,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},567,"人工股関節寛骨臼コンポーネント","35661000",0.0365854,0.145594,0.702528,0.016129,{"medical_device_id":89,"generic_name":90,"class_classification":40,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},848,"定位放射線治療用放射性核種システム","38298000",0.179487,0.106771,0.702278,0.015873,{"medical_device_id":97,"generic_name":98,"class_classification":58,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":95},2304,"整形外科用セメント吸引システム","34036000",0.3125,0.16318,0.638435,{"medical_device_id":104,"generic_name":105,"class_classification":40,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},597,"体外固定システム","35647003",0.132353,0.141844,0.698225,0.015625,{"medical_device_id":112,"generic_name":113,"class_classification":58,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":110},2505,"エアパッド特定加温装置システム","37328020",0.290323,0.122881,0.567825,[119,123,127,131,135,139,143,146,149,152,155,158],{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"OLO","Orthopedic Stereotaxic Instrument",439,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"HAW","Neurological Stereotaxic Instrument",424,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"SBF","Orthopedic Augmented Reality",43,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"PGW","Ear, Nose, And Throat Stereotaxic Instrument",37,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"ONN","Intraoperative Orthopedic Joint Assessment Aid",18,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"OEW","Tracking, Soft Tissue, Intraoperative",4,{"product_code":144,"device_name":145,"device_class":8,"k510_count":142},"OJP","Orthopedic Computer Controlled Surgical System",{"product_code":147,"device_name":148,"device_class":8,"k510_count":142},"ONA","Computer Assisted Hair Harvesting System",{"product_code":150,"device_name":151,"device_class":8,"k510_count":142},"ORR","Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri",{"product_code":153,"device_name":154,"device_class":8,"k510_count":31},"QRI","Surgical Planning Software For Neurological Stereotaxic Instruments",{"product_code":156,"device_name":157,"device_class":8,"k510_count":31},"SGE","Extracranial Positional System For A Transcranial Magnetic Stimulation System",{"product_code":159,"device_name":160,"device_class":8,"k510_count":34},"OSE","Patient Specific Manual Navigation System",{"510k":162,"classification":163,"enforcement":164,"event":165,"pma":166,"warning_letter":167},"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"]