K031859 is an FDA 510(k) clearance for the CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Arthrosurface, Inc. (Stoughton, US). The FDA issued a Cleared decision on February 18, 2004, 247 days after receiving the submission on June 16, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K031859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2003 |
| Decision Date | February 18, 2004 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| 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 |