The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica V40 22mm Femoral Head.
| Device ID | K950541 |
| 510k Number | K950541 |
| Device Name: | HOWMEDICA V40 22MM FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-07 |
| Decision Date | 1995-03-21 |