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FDA 510(k) Application Details - K182718
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K182718
Device Name
Plate, Fixation, Bone
Applicant
Gm Dos Reis Industria E Comerico Ltda.
Avenida Pierre Simon De La Place 600
Campinas 13069320 BR
Other 510(k) Applications for this Company
Contact
Paula Oliveira
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
09/28/2018
Decision Date
12/23/2019
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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