K052137 is an FDA 510(k) clearance for the ASCENSION MUH. This device is classified as a Prosthesis, Wrist, Hemi-, Ulnar (Class II - Special Controls, product code KXE).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on November 3, 2005, 90 days after receiving the submission on August 5, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3810.
| 510(k) Number | K052137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2005 |
| Decision Date | November 03, 2005 |
| Days to Decision | 90 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 |