The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Unitrax Modular Unipolar System.
| Device ID | K014226 |
| 510k Number | K014226 |
| Device Name: | UNITRAX MODULAR UNIPOLAR SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-26 |
| Decision Date | 2002-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327032529 | K014226 | 000 |
| 07613327032413 | K014226 | 000 |
| 07613327032406 | K014226 | 000 |
| 07613327032390 | K014226 | 000 |
| 07613327032383 | K014226 | 000 |
| 07613327032376 | K014226 | 000 |
| 07613327032369 | K014226 | 000 |
| 07613327032352 | K014226 | 000 |
| 07613327032345 | K014226 | 000 |
| 07613327032420 | K014226 | 000 |
| 07613327032437 | K014226 | 000 |
| 07613327032512 | K014226 | 000 |
| 07613327032505 | K014226 | 000 |
| 07613327032499 | K014226 | 000 |
| 07613327032482 | K014226 | 000 |
| 07613327032475 | K014226 | 000 |
| 07613327032468 | K014226 | 000 |
| 07613327032451 | K014226 | 000 |
| 07613327032444 | K014226 | 000 |
| 07613327032338 | K014226 | 000 |