FDA 510(k) Application Details - K223837

Device Classification Name	More FDA Info for this Device
510(K) Number	K223837
Device Name	SPIRA«-C Integrated Fixation System
Applicant	Camber Spine Technologies 501 Allendale Rd King of Prussia, PA 19406 US Other 510(k) Applications for this Company
Contact	Brooks McAdam Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2022
Decision Date	03/22/2023
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