K030384 is an FDA 510(k) clearance for the EVOLVE CERAMIC RADIAL HEAD IMPLANT. This device is classified as a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II - Special Controls, product code KWI).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 12, 2003, 188 days after receiving the submission on February 5, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3170.
| 510(k) Number | K030384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2003 |
| Decision Date | August 12, 2003 |
| Days to Decision | 188 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3170 |