K161782 is an FDA 510(k) clearance for the Arthrex Univers Revers Shoulder Prosthesis System. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 21, 2016, 145 days after receiving the submission on June 29, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K161782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2016 |
| Decision Date | November 21, 2016 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3690 |