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FDA 510(k) Application Details - K202143
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K202143
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
Vilex, LLC
111 Moffitt Street
McMinnville, TN 37110 US
Other 510(k) Applications for this Company
Contact
Joyce Thacker
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2020
Decision Date
09/11/2020
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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