K183194 is an FDA 510(k) clearance for the Arthrex Eclipse Shoulder Prosthesis System. This device is classified as a Total Shoulder Arthroplasty System (Class II - Special Controls, product code QHQ).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 26, 2019, 249 days after receiving the submission on November 19, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. To Treat Pain And Lack Of Function In The Shoulder..
| 510(k) Number | K183194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2018 |
| Decision Date | July 26, 2019 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QHQ — Total Shoulder Arthroplasty System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | To Treat Pain And Lack Of Function In The Shoulder. |