K083435 is an FDA 510(k) clearance for the ARTHREX UNIVERS II SHOULDER PEGGED GLENOID. 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 June 26, 2009, 218 days after receiving the submission on November 20, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K083435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2008 |
| Decision Date | June 26, 2009 |
| Days to Decision | 218 days |
| Submission Type | Special |
| 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 |