← Back to catalogue
FortiShield (Biosynthetic Wound Matrix)
FDA 510(k)U (US FDA 510(k))
510(k) K212579
Identifiers
- 510(k) Number
- K212579 FDA 510(k)
- FDA Product Code
- KGN FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
FortiShield (Biosynthetic Wound Matrix) by Organogenesis Inc. — U — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212579 | U | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Organogenesis Inc.
- FDA Applicant
- Organogenesis, Inc.
Sources (1)
- FDA 510(k) K212579 24 fields · synced Jun 18, 2026