K071016 is an FDA 510(k) clearance for the DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 4, 2007, 147 days after receiving the submission on April 10, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K071016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2007 |
| Decision Date | September 04, 2007 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM - Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |