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510(k) K230513

Arthrex Univers Apex OptiFit Humeral Stem by Arthrex, Inc. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2023
Date Received
February 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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