K112481 is an FDA 510(k) clearance for the FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT. This device is classified as a Prosthesis, Wrist, Hemi-, Ulnar (Class II - Special Controls, product code KXE).
Submitted by Ascension Orthopedic (Austin, US). The FDA issued a Cleared decision on April 9, 2012, 224 days after receiving the submission on August 29, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3810.
| 510(k) Number | K112481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2011 |
| Decision Date | April 09, 2012 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KXE — Prosthesis, Wrist, Hemi-, Ulnar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3810 |