The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Howmedica(r) 28mm Zirconia Femoral Heads.
| Device ID | K946026 |
| 510k Number | K946026 |
| Device Name: | HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-12 |
| Decision Date | 1995-03-20 |