[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OWR":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":116,"syncDates":263,"translation":30,"marketSummary":30,"recalls":270,"k510s":272,"pmas":281},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},6173,"OWR","Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery","2","878.3300","SU","General, Plastic Surgery","1","For reinforcement of soft tissue where weakness exists in facial plastic surgery.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":23,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":23,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":18,"fei_number":20,"registration_number":22},[19],"K201153",[21],"3027616027",[21],"","Y","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[34,43,52,60,68,76,84,92,100,108],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},170,"手術用吸収性メッシュ","Ⅳ","16048004",0.431034,0.12037,0.79505,0.0322665,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},1038,"非吸収性歯科用骨再建インプラント材","Ⅲ","34006003",0.271739,0.1375,0.8072,0.0295513,{"medical_device_id":53,"generic_name":54,"class_classification":37,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},238,"吸収性体内固定システム","35642004",0.287671,0.128405,0.730797,0.0289916,{"medical_device_id":61,"generic_name":62,"class_classification":37,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},237,"吸収性体内埋植用シート","70499000",0.292308,0.0440252,0.730691,0.028169,{"medical_device_id":69,"generic_name":70,"class_classification":37,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},235,"吸収性体内固定用プレート","35241004",0.314286,0.179775,0.700349,0.027365,{"medical_device_id":77,"generic_name":78,"class_classification":37,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},324,"吸収性歯科用骨再建インプラント材","34006004",0.23913,0.16129,0.772218,0.0271493,{"medical_device_id":85,"generic_name":86,"class_classification":46,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},514,"手術用メッシュ","16048003",0.241379,0.126904,0.782846,0.0269886,{"medical_device_id":93,"generic_name":94,"class_classification":37,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},260,"体内用吸収性合成・炭素繊維補綴材","33473204",0.220183,0.191964,0.744494,0.025817,{"medical_device_id":101,"generic_name":102,"class_classification":46,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},498,"非吸収性縫合糸セット","70425000",0.257576,0.152838,0.709772,0.0250039,{"medical_device_id":109,"generic_name":110,"class_classification":37,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},233,"吸収性体内固定用ボタン","70497000",0.273973,0.0689655,0.706404,0.0248534,[117,121,125,129,133,137,141,145,149,153,157,160,164,168,172,175,179,183,187,191,194,198,201,205,208,211,215,218,221,224,227,230,233,236,239,242,245,248,251,254,257,260],{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"FTL","Mesh, Surgical, Polymeric",336,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"FTM","Mesh, Surgical",163,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"OTN","Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator",65,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"JDK","Prosthesis, Hip, Cement Restrictor",54,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"LZN","Cement Obturator",37,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"OTO","Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed",23,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"PAH","Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling",20,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"OWY","Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon",14,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"OOD","Surgical Film",13,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"EZX","Mesh, Surgical, Metal",12,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"OTM","Mesh, Surgical, For Stress Urinary Incontinence, Male",{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"OWT","Mesh, Surgical, Absorbable, Abdominal Hernia",11,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"OWW","Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon",10,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"OXC","Mesh, Surgical, Absorbable, Staple Line Reinforcement",9,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"PAG","Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator",{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"OXF","Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery",8,{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"JDJ","Mesh, Surgical, Acetabular, Hip, Prosthesis",7,{"product_code":184,"device_name":185,"device_class":8,"k510_count":186},"ORQ","Mesh, Surgical, Deployer",6,{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"OWX","Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon",5,{"product_code":192,"device_name":193,"device_class":8,"k510_count":190},"OXH","Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery",{"product_code":195,"device_name":196,"device_class":8,"k510_count":197},"OXE","Mesh, Surgical, Collagen, Staple Line Reinforcement",4,{"product_code":199,"device_name":200,"device_class":8,"k510_count":197},"QUW","Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament",{"product_code":202,"device_name":203,"device_class":8,"k510_count":204},"OLC","Scaffold, Partial Medial Meniscal Defects Extending Into The Red\u002FWhite Zone, Resorbable Bovine Collagen",3,{"product_code":206,"device_name":207,"device_class":8,"k510_count":204},"OXD","Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement",{"product_code":209,"device_name":210,"device_class":8,"k510_count":204},"PIJ","Collagen Surgical Mesh Containing Drugs",{"product_code":212,"device_name":213,"device_class":8,"k510_count":214},"OXJ","Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects",2,{"product_code":216,"device_name":217,"device_class":8,"k510_count":214},"OXK","Mesh, Surgical, Collagen, Large Abdominal Wall Defects",{"product_code":219,"device_name":220,"device_class":8,"k510_count":214},"PAJ","Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed",{"product_code":222,"device_name":223,"device_class":8,"k510_count":31},"MCA","Tape, Surgical, Internal",{"product_code":225,"device_name":226,"device_class":8,"k510_count":31},"OQL","Mesh, Surgical, Deployment Balloon",{"product_code":228,"device_name":229,"device_class":8,"k510_count":31},"OWV","Mesh, Surgical, Collagen, Diaphragmatic Hernia",{"product_code":231,"device_name":232,"device_class":8,"k510_count":31},"OXN","Mesh, Surgical, Collagen, Fistula",{"product_code":234,"device_name":235,"device_class":8,"k510_count":31},"QWJ","Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament",{"product_code":237,"device_name":238,"device_class":8,"k510_count":29},"OWS","Mesh, Surgical, Collagen, Plastics, Facial Implants",{"product_code":240,"device_name":241,"device_class":8,"k510_count":29},"OWU","Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia",{"product_code":243,"device_name":244,"device_class":8,"k510_count":29},"OWZ","Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction",{"product_code":246,"device_name":247,"device_class":8,"k510_count":29},"OXA","Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction",{"product_code":249,"device_name":250,"device_class":8,"k510_count":29},"OXB","Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction",{"product_code":252,"device_name":253,"device_class":8,"k510_count":29},"OXG","Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery",{"product_code":255,"device_name":256,"device_class":8,"k510_count":29},"OXI","Mesh, Surgical, Absorbable, Large Abdominal Wall Defects",{"product_code":258,"device_name":259,"device_class":8,"k510_count":29},"OXL","Mesh, Surgical, Absorbable, Organ Support",{"product_code":261,"device_name":262,"device_class":8,"k510_count":29},"OXM","Mesh, Surgical, Absorbable, Fistula",{"510k":264,"classification":265,"enforcement":266,"event":267,"pma":268,"warning_letter":269},"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","2026-08-20T03:28:02.95+00:00",{"items":271,"total":29},[],{"items":273,"total":31},[274],{"k_number":19,"device_name":275,"applicant":276,"decision_date":277,"clearance_type":278,"decision_code":279,"statement_or_summary":280},"Tisuthes e-PTFE Surgical Patch","Shanghai Suokang Medical Implants Co., Ltd.","2023-06-13","Traditional","SESE","Summary",{"items":282,"total":29},[]]