The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Howmedica Threaded Acetabular Component.
| Device ID | K850840 |
| 510k Number | K850840 |
| Device Name: | HOWMEDICA THREADED ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Contact | Ronald Duchene |
| Correspondent | Ronald Duchene PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-07-15 |