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 |