K141920 is an FDA 510(k) clearance for the Wrist Hemiarthroplasty System. This device is classified as a Prosthesis, Wrist, Carpal Lunate (Class II - Special Controls, product code KWN).
Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on December 23, 2014, 160 days after receiving the submission on July 16, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3750.
| 510(k) Number | K141920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2014 |
| Decision Date | December 23, 2014 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWN - Prosthesis, Wrist, Carpal Lunate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3750 |