The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Modular Unipolar System.
| Device ID | K902365 |
| 510k Number | K902365 |
| Device Name: | MODULAR UNIPOLAR SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1991-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327013399 | K902365 | 000 |
| 07613327013382 | K902365 | 000 |
| 07613327013375 | K902365 | 000 |
| 07613327013368 | K902365 | 000 |