Collagen Tendon Wrap
FDA 510(k) K080452 · Collagen Matrix, Inc.
510(k) numberK080452
Submission
- Device name
- Collagen Tendon Wrap
- Applicant
- Collagen Matrix, Inc.
Franklin Lakes, NJ, US - Received
- February 19, 2008
- Decision date
- May 15, 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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Questions and answers
When was Collagen Tendon Wrap cleared by the FDA?
Collagen Tendon Wrap (K080452) received a 510(k) decision of Substantially Equivalent on May 15, 2008, 86 days after the submission was received.
What is the product code of K080452?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.