K041001 is an FDA 510(k) clearance for the OMEGA 2 SYSTEM. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on July 1, 2004, 73 days after receiving the submission on April 19, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K041001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2004 |
| Decision Date | July 01, 2004 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |