The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Pca Alumina Femoral Heads.
| Device ID | K063816 |
| 510k Number | K063816 |
| Device Name: | PCA ALUMINA FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Patricia Setti-laperch |
| Correspondent | Patricia Setti-laperch STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-02-02 |
| Summary: | summary |