FDA 510(k) Application Details - K212962

Device Classification Name	More FDA Info for this Device
510(K) Number	K212962
Device Name	TRELLISÖ SI Joint Fusion System
Applicant	OrthoFundamentals, LLC 173 Governors Ave Medford, MA 02155 US Other 510(k) Applications for this Company
Contact	Matthew Palmer 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	09/16/2021
Decision Date	04/11/2022
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