FDA 510(k) Application Details - K241895

Device Classification Name	More FDA Info for this Device
510(K) Number	K241895
Device Name	Cannulated PsiFGuard
Applicant	SpineGuard 10 Cours Louis Lumiere, 4th Floor Vincennes 94300 FR Other 510(k) Applications for this Company
Contact	Stephane Bette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2024
Decision Date	09/26/2024
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