The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ultima Metal-on-metal Acetabular Cup.
| Device ID | K001523 |
| 510k Number | K001523 |
| Device Name: | ULTIMA METAL-ON-METAL ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 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 | 2000-05-16 |
| Decision Date | 2000-08-10 |