K183077 is an FDA 510(k) clearance for the Delta Xtend Reverse Shoulder System. This device is classified as a Shoulder Prosthesis, Reverse Configuration (Class II - Special Controls, product code PHX).
Submitted by Depuy(Ireland) (Cork, IE). The FDA issued a Cleared decision on May 17, 2019, 193 days after receiving the submission on November 5, 2018.
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 | K183077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2018 |
| Decision Date | May 17, 2019 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| 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. |