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510(k) K183017

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer by Osteoremedies, LLC — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2019
Date Received
October 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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