[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OBT":3},{"classification":4,"mappedDevices":65,"similarCandidates":66,"relatedClassifications":147,"syncDates":236},{"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":15,"raw":16,"created_at":58,"updated_at":59,"recall_count":60,"latest_recall_date":61,"k510_count":62,"pma_count":63,"event_count":64},5216,"OBT","Plate, Bone, Growth Control, Pediatric, Epiphysiodesis","2","888.3030","OR","Orthopedic","1","Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis.  For gradually correcting angular deformities of long bones in pediatric patients with an open physis.  Specific conditions\u002Fdiseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and\u002For tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).  The device may be removed when growth has equalized or the growth plate has fused.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":54,"device_class":8,"implant_flag":55,"product_code":6,"review_panel":10,"gmp_exempt_flag":56,"third_party_flag":56,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":54,"life_sustain_support_flag":55,"medical_specialty_description":11,"summary_malfunction_reporting":57},{"k_number":18,"fei_number":25,"registration_number":47},[19,20,21,22,23,24],"K172183","K182704","K180624","K220190","K093442","K110805",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"1526534","3009322142","3002807827","3002949614","3005061536","3009631939","3013680140","3006460162","3014314623","1828464","1824313","3007125392","3007539489","2183449","1000069183","3007993775","1828288","1000306340","3003414678","3000327445","3002807395",[48,26,49,50,29,30,31,32,33,34,35,36,51,37,38,39,52,53,41,42,45],"1834331","9611281","9680825","3006783837","1527105","9616944","","Y","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",1,"2024-05-22",6,0,10,[],[67,76,84,93,102,109,117,124,132,139],{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},2536,"電気骨折治療器","Ⅱ","35463000",0.235294,0.196121,0.696503,0.0327869,{"medical_device_id":77,"generic_name":78,"class_classification":70,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},2478,"超音波骨折治療器","18154000",0.2,0.125356,0.670739,0.0312805,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},4345,"整復桿","Ⅰ","32862000",0.0909091,0.220109,0.692226,0.016129,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},1102,"患者適合型体内固定用プレート","Ⅲ","35241023",0.0705882,0.243243,0.679463,0.015873,{"medical_device_id":103,"generic_name":104,"class_classification":70,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":101},2502,"電気パッド加温装置コントロールユニット","36955000",0.183099,0.16,0.520361,{"medical_device_id":110,"generic_name":111,"class_classification":70,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},2622,"歯科小児用ユニット","70724000",0.16129,0.23913,0.596338,0.015625,{"medical_device_id":118,"generic_name":119,"class_classification":87,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":116},4308,"再使用可能な骨接合用器械","70958001",0.0641026,0.185792,0.675596,{"medical_device_id":125,"generic_name":126,"class_classification":96,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":131},594,"体内固定用プレート","35241003",0.0857143,0.237473,0.671005,0.0153846,{"medical_device_id":133,"generic_name":134,"class_classification":96,"jmdn_code":135,"name_similarity":136,"definition_similarity":137,"vector_similarity":138,"score":131},779,"新生児・小児用人工呼吸器","14361000",0.15942,0.246521,0.538818,{"medical_device_id":140,"generic_name":141,"class_classification":96,"jmdn_code":142,"name_similarity":143,"definition_similarity":144,"vector_similarity":145,"score":146},619,"人工股関節骨セメントレストリクタ","33180000",0.157895,0.197861,0.635713,0.0151515,[148,152,156,160,164,168,172,176,180,184,188,192,196,200,204,207,211,214,218,221,224,227,230,233],{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"HRS","Plate, Fixation, Bone",1320,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"KTT","Appliance, Fixation, Nail\u002FBlade\u002FPlate Combination, Multiple Component",404,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"JDR","Staple, Fixation, Bone",232,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"MAI","Fastener, Fixation, Biodegradable, Soft Tissue",221,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"HTN","Washer, Bolt Nut",93,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"LXT","Appliance, Fixation, Nail\u002FBlade\u002FPlate Combination, Multiple Component, Metal Composite",57,{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"JDS","Nail, Fixation, Bone",53,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"KTW","Appliance, Fixation, Nail\u002FBlade\u002FPlate Combination, Single Component",38,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"PBF","Orthopaedic Surgical Planning And Instrument Guides",27,{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"JDO","Device, Fixation, Proximal Femoral, Implant",23,{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"PLF","Bone Wedge",18,{"product_code":193,"device_name":194,"device_class":8,"k510_count":195},"LYT","Fixation Accessory",9,{"product_code":197,"device_name":198,"device_class":8,"k510_count":199},"LRN","Wire, Surgical",8,{"product_code":201,"device_name":202,"device_class":8,"k510_count":203},"MNU","Staple, Absorbable",4,{"product_code":205,"device_name":206,"device_class":8,"k510_count":203},"OSN","Software For Diagnosis\u002FTreatment",{"product_code":208,"device_name":209,"device_class":8,"k510_count":210},"NDF","Plate, Fixation, Bone, Non-Spinal, Metallic",3,{"product_code":212,"device_name":213,"device_class":8,"k510_count":210},"OZI","Internal Hinged Elbow Fixator",{"product_code":215,"device_name":216,"device_class":8,"k510_count":217},"JDP","Condylar Plate Fixation Implant",2,{"product_code":219,"device_name":220,"device_class":8,"k510_count":60},"KWK","Appliance, Nail\u002FBlade\u002FPlate Combination, Single Component",{"product_code":222,"device_name":223,"device_class":8,"k510_count":60},"NDG","Washer, Bolt, Nut, Non-Spinal, Metallic",{"product_code":225,"device_name":226,"device_class":8,"k510_count":60},"NOV","Anchor, Suture, Bone Fixation, Metallic",{"product_code":228,"device_name":229,"device_class":8,"k510_count":60},"OOL","Electronic Depth Gauge",{"product_code":231,"device_name":232,"device_class":8,"k510_count":63},"NDH","Nail, Fixation, Bone, Metallic",{"product_code":234,"device_name":235,"device_class":8,"k510_count":63},"NDI","Staple, Fixation, Bone, Metallic",{"510k":237,"classification":238,"enforcement":239,"event":240,"pma":241,"warning_letter":242},"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"]