[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PBJ":3},{"classification":4,"mappedDevices":49,"similarCandidates":50,"relatedClassifications":131,"syncDates":140},{"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":43,"updated_at":44,"recall_count":45,"latest_recall_date":46,"k510_count":47,"pma_count":45,"event_count":48},3093,"PBJ","Cranial Distraction System","2","882.5330","NE","Neurology","1","A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull.  The bone segments are attached to the plate with screws to prevent movement of the segments.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":39,"device_class":8,"implant_flag":40,"product_code":6,"review_panel":10,"gmp_exempt_flag":41,"third_party_flag":41,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":39,"life_sustain_support_flag":40,"medical_specialty_description":11,"summary_malfunction_reporting":42},{"k_number":18,"fei_number":25,"registration_number":35},[19,20,21,22,23,24],"K121304","K123885","K163315","K150771","K230211","K170818",[26,27,28,29,30,31,32,33,34],"3006017180","3002807464","3008868758","2027754","3001236277","1000525271","3015212339","3008812560","3009417901",[36,26,37,28,29,38,32,33,34],"9610905","1649518","1057946","","Y","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",0,null,6,18,[],[51,60,69,77,85,92,100,108,117,125],{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},596,"頭蓋骨固定用クランプ","Ⅲ","70500000",0.268293,0.252708,0.760239,0.0322665,{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},4301,"伸延器","Ⅰ","11291000",0.266667,0.197368,0.743697,0.0315136,{"medical_device_id":70,"generic_name":71,"class_classification":54,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},602,"脊椎内固定器具","37272003",0.244444,0.228669,0.680202,0.0267094,{"medical_device_id":78,"generic_name":79,"class_classification":63,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},4205,"頭蓋骨用バー","10520001",0.258065,0.222222,0.667562,0.0262001,{"medical_device_id":86,"generic_name":87,"class_classification":54,"jmdn_code":88,"name_similarity":82,"definition_similarity":89,"vector_similarity":90,"score":91},595,"体内固定システム","35642003",0.203333,0.674079,0.0234568,{"medical_device_id":93,"generic_name":94,"class_classification":63,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},3840,"吸引器用キャニスタ","34858000",0.358974,0.213622,0.486679,0.0163934,{"medical_device_id":101,"generic_name":102,"class_classification":54,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},950,"超音波吸引器","37776000",0.3,0.157051,0.568963,0.016129,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},1085,"吸収性頭蓋骨固定用クランプ","Ⅳ","70500004",0.211538,0.254098,0.741463,0.015873,{"medical_device_id":118,"generic_name":119,"class_classification":54,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":124},753,"血液濾過用装置","35453000",0.289474,0.0994475,0.549647,0.015625,{"medical_device_id":126,"generic_name":127,"class_classification":63,"jmdn_code":128,"name_similarity":45,"definition_similarity":129,"vector_similarity":130,"score":124},4302,"骨タップ","17507000",0.246154,0.729526,[132,136],{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"GXN","Plate, Cranioplasty, Preformed, Non-Alterable",57,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"PJN","Filler, Bone Void, Non-Alterable Compound For Cranioplasty",2,{"510k":141,"classification":142,"enforcement":143,"event":144,"pma":145,"warning_letter":146},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]