K033930 is an FDA 510(k) clearance for the KAPP CUSTOM ULNAR HEAD WRIST IMPLANT. This device is classified as a Prosthesis, Wrist, Hemi-, Ulnar (Class II - Special Controls, product code KXE).
Submitted by Kapp Surgical Instrument, Inc. (Warrensville, US). The FDA issued a Cleared decision on July 28, 2004, 223 days after receiving the submission on December 18, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3810.
| 510(k) Number | K033930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2003 |
| Decision Date | July 28, 2004 |
| Days to Decision | 223 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 |