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FDA 510(k) Application Details - K231831
Device Classification Name
More FDA Info for this Device
510(K) Number
K231831
Device Name
TiLink-L Joint Fusion System
Applicant
SurGenTec
911 Clint Moore Rd
Boca Raton, FL 33487 US
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Contact
Andrew Shoup
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Regulation Number
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Classification Product Code
OUR
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More FDA Info for this Product Code
Date Received
06/22/2023
Decision Date
08/03/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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