K212579 is an FDA 510(k) clearance for the FortiShield (Biosynthetic Wound Matrix). This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on May 2, 2023, 624 days after receiving the submission on August 16, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K212579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2021 |
| Decision Date | May 02, 2023 |
| Days to Decision | 624 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |