FDA 510(k) Application Details - K241117

Device Classification Name	More FDA Info for this Device
510(K) Number	K241117
Device Name	M6-CÖ Single Use, Disposable Instrumentation
Applicant	Spinal Kinetics / Orthofix / SeaSpine 501 Mercury Drive Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Tony John Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2024
Decision Date	06/21/2024
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