K093275 is an FDA 510(k) clearance for the EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER. This device is classified as a Shoulder Prosthesis, Reverse Configuration (Class II - Special Controls, product code PHX).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 27, 2010, 220 days after receiving the submission on October 19, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint..
| 510(k) Number | K093275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2009 |
| Decision Date | May 27, 2010 |
| Days to Decision | 220 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PHX — Shoulder Prosthesis, Reverse Configuration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint. |