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510(k) K201072

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 by Ensemble Orthopedics, LLC — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2020
Date Received
April 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
Review Panel
OR
Submission Type

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