The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for It-7 Femoral Component, Anatomic Hip System.
| Device ID | K925153 |
| 510k Number | K925153 |
| Device Name: | IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary Spicer |
| Correspondent | Mary Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1994-03-01 |