The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Restore Orthobiologic Soft Tissue Implant.
| Device ID | K071016 |
| 510k Number | K071016 |
| Device Name: | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
| Classification | Mesh, Surgical |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Kathy Harris |
| Correspondent | Kathy Harris DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-10 |
| Decision Date | 2007-09-04 |
| Summary: | summary |