The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Partnership Calcar Femoral Components.
| Device ID | K980239 |
| 510k Number | K980239 |
| Device Name: | PARTNERSHIP CALCAR FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Frank Maaa |
| Correspondent | Frank Maaa HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-04-16 |
| Summary: | summary |