The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Omega 3 Supracondylar Plate.
| Device ID | K070454 |
| 510k Number | K070454 |
| Device Name: | OMEGA 3 SUPRACONDYLAR PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-04-12 |
| Summary: | summary |