The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for V40 Zirconia Femoral Heads.
| Device ID | K972361 |
| 510k Number | K972361 |
| Device Name: | V40 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 | Frank Maas |
| Correspondent | Frank Maas 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 | 1997-06-25 |
| Decision Date | 1997-09-23 |
| Summary: | summary |