FDA 510(k) Application Details - K223114

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K223114
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
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	Iara Guimaraes Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2022
Decision Date	08/02/2023
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