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510(k) K151527

Arthrex Univers Revers CA Heads and Adapters by Arthrex, Inc. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2016
Date Received
June 8, 2015
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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  • K161620 — Anatomical Shoulder Domelock Dome centric (November 1, 2016)
  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)
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