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510(k) K241043

Augment Off-Axis Instrument System by Fix Surgical — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2024
Date Received
April 17, 2024
Clearance Type
Special
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.

Other clearances by Fix Surgical

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