FDA 510(k) Application Details - K201728

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K201728
Device Name	Plate, Fixation, Bone
Applicant	GM dos Reis Industria e Comercio 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	06/23/2020
Decision Date	03/08/2021
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