The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Pinnacle Constrained Acetabular Liners.
| Device ID | K043058 |
| 510k Number | K043058 |
| Device Name: | PINNACLE CONSTRAINED ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Contact | Natalie Heck |
| Correspondent | Natalie Heck DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2005-03-14 |
| Summary: | summary |