[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QFP":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":108,"syncDates":109,"translation":116,"marketSummary":123,"recalls":136,"k510s":138,"pmas":145},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},5244,"QFP","Intraoperative Orthopedic Strain Sensor","2","888.3090","OR","Orthopedic","1","A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":19,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":19,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"DEN180012","","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:48.366308+00:00",0,null,1,[],[29,38,46,55,63,70,78,85,93,100],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":35,"vector_similarity":36,"score":37},4326,"整形外科用カリパ","Ⅰ","35788000",0.272727,0.151786,0.680383,0.0300905,{"medical_device_id":39,"generic_name":40,"class_classification":32,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},4328,"整形外科用やすり","36167001",0.261905,0.133028,0.667412,0.0278638,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},2902,"整形外科装具挿入器","Ⅱ","13180000",0.223881,0.249211,0.681588,0.0276515,{"medical_device_id":56,"generic_name":57,"class_classification":49,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},3185,"人工関節置換術用荷重センサユニット","58988002",0.103896,0.164912,0.744352,0.0163934,{"medical_device_id":64,"generic_name":65,"class_classification":32,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":62},3870,"整形外科用手術台","35394000",0.319149,0.193103,0.622069,{"medical_device_id":71,"generic_name":72,"class_classification":49,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},2369,"ポジショニングセンサ","43267000",0.142857,0.193651,0.721736,0.016129,{"medical_device_id":79,"generic_name":80,"class_classification":49,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":77},2880,"手動式整形外科用注入器","70956000",0.303571,0.194215,0.651284,{"medical_device_id":86,"generic_name":87,"class_classification":49,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1316,"術中用超音波プローブカバー","70016000",0.275862,0.20339,0.622152,0.015873,{"medical_device_id":94,"generic_name":95,"class_classification":32,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":92},4341,"臨床的骨測深器","32845000",0.0175439,0.1625,0.697946,{"medical_device_id":101,"generic_name":102,"class_classification":49,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},1634,"定量的感覚検査用パルポメータ","40817000",0.15625,0.163265,0.689631,0.015625,[],{"510k":110,"classification":111,"enforcement":112,"event":113,"pma":114,"warning_letter":115},"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":117,"definition_ja":118,"commentary_ja":119,"model_name":120,"source_hash":121,"reviewed_by":25,"reviewed_at":25,"created_at":122,"updated_at":122},"術中整形外科用ストレインセンサ","ストレインセンサ機器は、術中の状況においてのみ整形外科用インプラントにかかるストレインを測定することを目的とした補助的な器具である。本機器は、診断情報を提供すること、または臨床上の意思決定に影響を与えることを目的としていない。","米国ではクラスIIに分類され、市販前届出（510(k)）による審査区分の対象となっています。これは、製造販売に際して既存の同等な機器との実質的同等性を示すことで市販が認められる区分であり、クラスIIIの機器に求められる市販前承認（PMA）と比較して相対的にリスクが低いと位置づけられていることを意味します。","claude-sonnet-5","cda34f8bfff8683b1e1b1e2cd0382ef86baf2cf9650c926625704df6cf4cb3fe","2026-08-24T02:37:21.239845+00:00",{"product_code":6,"summary_ja":124,"stats":125,"stats_hash":134,"model_name":120,"created_at":135,"updated_at":135},"本製品分野における510(k)の累計件数は1件で、参入企業数は1社にとどまり、直近5年間の届出実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告や回収事例は確認されていません。",{"pma":126,"k510":127,"as_of":129,"events":130,"recalls":131,"top_problems":133},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":128,"applicants":26},"2019-03-28","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":132},[],[],"53d87a6aebd13a00e1976cd982f215b0b145ac648e6cdc32bdb27b9d45ef8cbd","2026-08-24T05:16:12.270965+00:00",{"items":137,"total":24},[],{"items":139,"total":26},[140],{"k_number":18,"device_name":141,"applicant":142,"decision_date":128,"clearance_type":143,"decision_code":144,"statement_or_summary":25},"LOADPRO™ Intraoperative Rod Strain Sensor","Intellirod Spine, Inc.","Direct","DENG",{"items":146,"total":24},[]]