K203228 is an FDA 510(k) clearance for the DART-FIRE EDGE Cannulated Screw System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Wright Medical (Memphis, US). The FDA issued a Cleared decision on May 11, 2021, 190 days after receiving the submission on November 2, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K203228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | May 11, 2021 |
| Days to Decision | 190 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 |