Veritas Collagen Matrix (Dry)
FDA 510(k) K083039 · Synovis Surgical Innovations
510(k) numberK083039
Submission
- Device name
- Veritas Collagen Matrix (Dry)
- Applicant
- Synovis Surgical Innovations
St. Paul, MN, US - Received
- October 14, 2008
- Decision date
- November 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K122306 | Synovis Collagen Matrix (TBD)DXZ · Traditional | 03/08/2013SE |
| K062915 | Veritas Collagen MatrixFTM · Traditional | 12/06/2006SE |
| K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDFTM · Traditional | 10/27/2004SE |
| K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…DXZ · Traditional | 04/14/2004SE |
| K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…FTM · Traditional | 03/17/2004SE |
| K040001 | Steerable StyletDRB · Traditional | 03/09/2004SE |
| K030879 | Veritas Collagen MatrixOXE · Traditional | 04/24/2003SE |
Questions and answers
When was Veritas Collagen Matrix (Dry) cleared by the FDA?
Veritas Collagen Matrix (Dry) (K083039) received a 510(k) decision of Substantially Equivalent on November 26, 2008, 43 days after the submission was received.
What is the product code of K083039?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.