The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Modification To Pinnacle Constrained Acetabular Liners.
| Device ID | K071117 |
| 510k Number | K071117 |
| Device Name: | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Contact | Natalie Heck |
| Correspondent | Natalie Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-20 |
| Decision Date | 2007-05-18 |
| Summary: | summary |