K001738 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 December 27, 2000, 203 days after receiving the submission on June 7, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K001738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2000 |
| Decision Date | December 27, 2000 |
| Days to Decision | 203 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 |