K050634 is an FDA 510(k) clearance for the MODIFICATION TO: ARTHREX V-TAK. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 21, 2005, 12 days after receiving the submission on March 9, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K050634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2005 |
| Decision Date | March 21, 2005 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |