The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Eius Unicompartmental Knee System.
| Device ID | K033769 |
| 510k Number | K033769 |
| Device Name: | EIUS UNICOMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-03 |
| Decision Date | 2004-02-13 |
| Summary: | summary |