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FDA 510(k) Application Details - K201510
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K201510
Device Name
Plate, Fixation, Bone
Applicant
Fixier, S.A. de C.V.
Calle Joaquφn PardavΘ No. 223
Colonia Casa Blanca
Leon C.P. 37170 MX
Other 510(k) Applications for this Company
Contact
Vianey Mariana Perez Suarez
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
06/05/2020
Decision Date
02/18/2022
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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