The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Pinnacle Metal-on-metal Acetabular Cup Liners.
| Device ID | K083642 |
| 510k Number | K083642 |
| Device Name: | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Dawn Sinclair |
| Correspondent | Dawn Sinclair DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2009-03-06 |
| Summary: | summary |