K001385 is an FDA 510(k) clearance for the HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS. This device is classified as a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II - Special Controls, product code KWI).
Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on July 27, 2000, 86 days after receiving the submission on May 2, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3170.
| 510(k) Number | K001385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2000 |
| Decision Date | July 27, 2000 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| 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 |