FTM — Mesh, Surgical Class II
FDA Device Classification
Classification Details
- Product Code
- FTM
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250598 | aroa biosurgery | Endoform Reconstructive Template - PLGA | June 3, 2025 |
| K243595 | tela bio | OviTex PRS (Long-Term Resorbable) | December 19, 2024 |
| K233991 | elutia | CanGaroo RM Antibacterial Envelope | June 14, 2024 |
| K241126 | tela bio | OviTex PRS | May 22, 2024 |
| K223052 | synovis life technologies | Peri-Guard and Supple Peri-Guard | April 7, 2023 |
| K214070 | tela bio | OviTex PRS (Long Term Resorbable) | March 21, 2023 |
| K213163 | alafair biosciences | VersaWrap | October 29, 2021 |
| K213125 | synovis life technologies. inc. (a subsidiary of baxter | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU | October 27, 2021 |
| K203496 | geistlich pharma | Nexo-Gide Bilayer Collagen Membrane | July 14, 2021 |
| K203600 | alafair biosciences | VersaWrap | March 9, 2021 |
| K192452 | b. bruan surgical | Lyograft | September 3, 2020 |
| K201000 | cook biotech incorporated | Biodesign Staple Line Reinforcement | July 13, 2020 |
| K201313 | aziyo biologics | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) | June 15, 2020 |
| K200311 | alafair biosciences | VersaWrap Tendon Protector | March 6, 2020 |
| K192615 | synovis life technologies, inc. (baxter international inc.) | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-S | December 17, 2019 |
| K192616 | aziyo biologics | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) | October 21, 2019 |
| K182493 | tisgenx | Bovine Pericardial Tissue Patch | June 18, 2019 |
| K183398 | aroa biosurgery | Endoform Restella | April 11, 2019 |
| K183472 | synthes (usa) products | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Con | March 13, 2019 |
| K182259 | acell | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | February 7, 2019 |