Propatch Soft Tissue Repair Matrix
FDA 510(k) K110581 · Cryolife, Inc.
510(k) numberK110581
Submission
- Device name
- Propatch Soft Tissue Repair Matrix
- Applicant
- Cryolife, Inc.
Kennesaw, GA, US - Received
- March 1, 2011
- Decision date
- January 10, 2012
- 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 Propatch Soft Tissue Repair Matrix cleared by the FDA?
Propatch Soft Tissue Repair Matrix (K110581) received a 510(k) decision of Substantially Equivalent on January 10, 2012, 315 days after the submission was received.
What is the product code of K110581?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.