The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Howmedica Straight Stem Femoral Component.
| Device ID | K940307 |
| 510k Number | K940307 |
| Device Name: | HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1995-01-19 |