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FDA 510(k) Application Details - K202611
Device Classification Name
More FDA Info for this Device
510(K) Number
K202611
Device Name
Catalyst OrthoScience R1 Reverse Shoulder System
Applicant
Catalyst OrthoScience, Inc.
14710 Tamiami Trail North
Naples, FL 34110 US
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Contact
Dale Davison
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2020
Decision Date
02/12/2021
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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