Tendon Wrap Tendon Protector
FDA 510(k) K053655 · Integra LifeSciences Corporation
510(k) numberK053655
Submission
- Device name
- Tendon Wrap Tendon Protector
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- December 30, 2005
- Decision date
- February 3, 2006
- 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 Tendon Wrap Tendon Protector cleared by the FDA?
Tendon Wrap Tendon Protector (K053655) received a 510(k) decision of Substantially Equivalent on February 3, 2006, 35 days after the submission was received.
What is the product code of K053655?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.