K944507 is an FDA 510(k) clearance for the METALLIC RADIAL HEAD IMPLANTS. 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 July 13, 1995, 301 days after receiving the submission on September 15, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3170.
| 510(k) Number | K944507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 15, 1994 |
| Decision Date | July 13, 1995 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3170 |