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FDA 510(k) Application Details - K212348
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K212348
Device Name
Plate, Fixation, Bone
Applicant
Vilex LLC
111 Moffitt Street
McMinnville, TN 37110 US
Other 510(k) Applications for this Company
Contact
Louis Monaco
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/28/2021
Decision Date
05/02/2022
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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