ENDOFORM RECONSTRUCTIVE TEMPLATE
FDA 510(k) clearance K130547 · decided 2013-05-31
Clearance details
- K-number
- K130547
- Device name
- ENDOFORM RECONSTRUCTIVE TEMPLATE
- Applicant
- Mesynthe, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-04
- Decision date
- 2013-05-31
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Endoform Reconstructive Template - PLGA (K250598) | Aroa Biosurgery , Ltd. | 2025-06-03 |
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| CanGaroo RM Antibacterial Envelope (K233991) | Elutia, Inc. | 2024-06-14 |
| OviTex PRS (K241126) | TELA Bio, Inc. | 2024-05-22 |
| Peri-Guard and Supple Peri-Guard (K223052) | Synovis Life Technologies, Inc. | 2023-04-07 |
| OviTex PRS (Long Term Resorbable) (K214070) | Tela Bio | 2023-03-21 |
| VersaWrap (K213163) | Alafair Biosciences, Inc. | 2021-10-29 |
| PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K213125) | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021-10-27 |
| Nexo-Gide Bilayer Collagen Membrane (K203496) | Geistlich Pharma AG | 2021-07-14 |
| VersaWrap (K203600) | Alafair Biosciences, Inc. | 2021-03-09 |
| Lyograft (K192452) | B. Bruan Surgical, SA | 2020-09-03 |
| Biodesign Staple Line Reinforcement (K201000) | Cook Biotech Incorporated | 2020-07-13 |
Recalls involving this device
No recalls on record reference this clearance.