{"product_id":"fda-510k-k203267-the-biobrace-implant","title":"FDA 510(k) K203267, The BioBrace Implant, by Biorez, Inc.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eThe BioBrace Implant\u003c\/strong\u003e (K203267), submitted by Biorez, Inc..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K203267\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Biorez, Inc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 11\/05\/2020\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 04\/30\/2021\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 878.33\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e OWW\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product Code:\u003c\/strong\u003e OWY\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 4272 (4157 unredacted, 2% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e— \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eDevice Description:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eClinical Data:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51463797506212,"sku":"FDA510K203267","price":895.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k203267-the-biobrace-implant","provider":"FOIA Document Source","version":"1.0","type":"link"}