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510(k) K173717

Integra TITAN Reverse Shoulder System by Integra LifeSciences Corporation — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2018
Date Received
December 5, 2017
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.

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