The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Constrained Acetabular Liners.
| Device ID | K052079 |
| 510k Number | K052079 |
| Device Name: | PINNACLE CONSTRAINED ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Keli K Hankee |
| Correspondent | Keli K Hankee DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-10-21 |
| Summary: | summary |