FDA 510(k) Application Details - K243265

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K243265
Device Name	System, Facet Screw Spinal Device
Applicant	SurGenTec, LLC 911 Clint More Rd Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Richard Sharp Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2024
Decision Date	12/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review