The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Acetabular System.
| Device ID | K001534 |
| 510k Number | K001534 |
| Device Name: | PINNACLE ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2000-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295011859 | K001534 | 000 |
| 10603295011842 | K001534 | 000 |
| 10603295011835 | K001534 | 000 |
| 10603295011828 | K001534 | 000 |
| 10603295011811 | K001534 | 000 |
| 10603295011804 | K001534 | 000 |
| 10603295011798 | K001534 | 000 |
| 10603295011781 | K001534 | 000 |