K010124 is an FDA 510(k) clearance for the ARTHREX UNIVERS 30 SHOULDER PROSTHESIS. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 6, 2001, 80 days after receiving the submission on January 16, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K010124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2001 |
| Decision Date | April 06, 2001 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |