The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Howmedica Alumina Femoral Head.
| Device ID | K915184 |
| 510k Number | K915184 |
| Device Name: | HOWMEDICA ALUMINA FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Denise E Murphy |
| Correspondent | Denise E Murphy PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1992-01-31 |