K100741 is an FDA 510(k) clearance for the REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012. This device is classified as a Shoulder Prosthesis, Reverse Configuration (Class II - Special Controls, product code PHX).
Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on August 2, 2010, 139 days after receiving the submission on March 16, 2010.
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 | K100741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2010 |
| Decision Date | August 02, 2010 |
| Days to Decision | 139 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. |