Depuy Restore Orthobiologic Soft Tissue Implant
FDA 510(k) K071016 · DePuy Orthopaedics, Inc.
510(k) numberK071016
Submission
- Device name
- Depuy Restore Orthobiologic Soft Tissue Implant
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- April 10, 2007
- Decision date
- September 4, 2007
- 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 Depuy Restore Orthobiologic Soft Tissue Implant cleared by the FDA?
Depuy Restore Orthobiologic Soft Tissue Implant (K071016) received a 510(k) decision of Substantially Equivalent on September 4, 2007, 147 days after the submission was received.
What is the product code of K071016?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.