VERITAS COLLAGEN MATRIX
FDA 510(k) clearance K062915 · decided 2006-12-06
Clearance details
- K-number
- K062915
- Device name
- VERITAS COLLAGEN MATRIX
- Applicant
- Synovis Surgical Innovations
- Decision
- Substantially Equivalent
- Date received
- 2006-09-27
- Decision date
- 2006-12-06
- Days to decision
- 70 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
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT (P780002/S012) | Synovis Surgical Innovations | 1995-11-24 |
| DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE (P780002/S008) | Synovis Surgical Innovations | 1990-09-11 |
| DARDIK BIOGRAFT (P780002/S005) | Synovis Surgical Innovations | 1986-05-19 |
| DARDIK BIOGRAFT (P780002/S002) | Synovis Surgical Innovations | 1981-12-01 |
| DARDIK BIOGRAFT (P780002/S004) | Synovis Surgical Innovations | 1981-11-30 |
| DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR (P780002/S001) | Synovis Surgical Innovations | 1981-07-10 |
| DARDIK BIOGRAFT (P780002) | Synovis Surgical Innovations | 1979-01-17 |