The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Pinnacle Altrx Acetabular Cup Liner.
| Device ID | K062148 |
| 510k Number | K062148 |
| Device Name: | DEPUY PINNACLE ALTRX ACETABULAR CUP LINER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Anne M Schuler |
| Correspondent | Anne M Schuler DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2006-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295016779 | K062148 | 000 |
| 10603295016762 | K062148 | 000 |
| 10603295016755 | K062148 | 000 |
| 10603295016748 | K062148 | 000 |
| 10603295016731 | K062148 | 000 |
| 10603295016724 | K062148 | 000 |
| 10603295016717 | K062148 | 000 |
| 10603295016700 | K062148 | 000 |