510(k) K191146
K191146 is an FDA 510(k) premarket notification submitted by Fx Shoulder USA, Inc. for the device "Humelock TiN Coated Glenosphere". The FDA issued a decision of Substantially Equivalent on July 15, 2020. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Fx Shoulder USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2020
- Date Received
- April 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoulder Prosthesis, Reverse Configuration
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type
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.