K080667 is an FDA 510(k) clearance for the VARIAX DISTAL RADIUS TORX SCREWS. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on March 19, 2008, 9 days after receiving the submission on March 10, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K080667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2008 |
| Decision Date | March 19, 2008 |
| Days to Decision | 9 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |