K091069 is an FDA 510(k) clearance for the MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Medacta International S.A. (San Diego, US). The FDA issued a Cleared decision on June 1, 2009, 48 days after receiving the submission on April 14, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K091069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2009 |
| Decision Date | June 01, 2009 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| 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 |