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510(k) K152267

Remedy® Shoulder Spacer by Osteoremedies, LLC — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2015
Date Received
August 11, 2015
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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