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FDA 510(k) Application Details - K213349
Device Classification Name
More FDA Info for this Device
510(K) Number
K213349
Device Name
Catalyst R1 Reverse Shoulder System
Applicant
Catalyst OrthoScience, Inc
14710 Tamiami Trail North, Suite 102
Naples, FL 34110 US
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Contact
Dale Davison
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Regulation Number
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Classification Product Code
PHX
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More FDA Info for this Product Code
Date Received
10/08/2021
Decision Date
06/23/2022
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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