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FDA 510(k) Application Details - K201072
Device Classification Name
Prosthesis, Wrist, Carpal Trapezium
More FDA Info for this Device
510(K) Number
K201072
Device Name
Prosthesis, Wrist, Carpal Trapezium
Applicant
Ensemble Orthopedics, LLC
107 Redbud Trail, Suite 11
Austin, TX 78746 US
Other 510(k) Applications for this Company
Contact
Sandie Roth
Other 510(k) Applications for this Contact
Regulation Number
888.3770
More FDA Info for this Regulation Number
Classification Product Code
KYI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2020
Decision Date
12/02/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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