The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Unitrax V40 Modular Adaptor.
| Device ID | K954077 |
| 510k Number | K954077 |
| Device Name: | UNITRAX V40 MODULAR ADAPTOR |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe 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 | 1995-08-30 |
| Decision Date | 1995-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327013443 | K954077 | 000 |
| 07613327013436 | K954077 | 000 |
| 07613327013429 | K954077 | 000 |
| 07613327013412 | K954077 | 000 |
| 07613327013405 | K954077 | 000 |