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510(k) K161782

Arthrex Univers Revers Shoulder Prosthesis System by Arthrex, Inc. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2016
Date Received
June 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type

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  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)
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