FDA 510(k) Application Details - K233972

Device Classification Name	More FDA Info for this Device
510(K) Number	K233972
Device Name	Camber Sacroiliac (SI) Fixation System
Applicant	Camber Spine Technologies 501 Allendale Road 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	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2023
Decision Date	02/27/2024
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