FDA 510(k) Application Details - K212381

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K212381
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Ortho-Design (Pty) Ltd 472 Botterklapper Street, Die Wilgers Pretoria 0184 ZA Other 510(k) Applications for this Company
Contact	Dian Peach 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	08/02/2021
Decision Date	12/06/2021
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