K030319 is an FDA 510(k) clearance for the ORTHOSPHERE CERAMIC SPHERICAL IMPLANT. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on November 26, 2003, 300 days after receiving the submission on January 30, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K030319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2003 |
| Decision Date | November 26, 2003 |
| Days to Decision | 300 days |
| Submission Type | Abbreviated |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD — Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |