The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Reclaim Revision Hip System.
| Device ID | K102080 |
| 510k Number | K102080 |
| Device Name: | DEPUY RECLAIM REVISION HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY (IRELAND) 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY (IRELAND) 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-26 |
| Decision Date | 2010-11-23 |
| Summary: | summary |