FDA 510(k) Application Details - K221447

Device Classification Name	More FDA Info for this Device
510(K) Number	K221447
Device Name	Southern Anterior Screw Fixated Cage (SASCA)
Applicant	Southern Medical (Pty) Ltd 55 Regency Drive, Route 21 Corporate Park Irene 0178 ZA Other 510(k) Applications for this Company
Contact	Dalene Styger Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2022
Decision Date	10/14/2022
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