FDA 510(k) Application Details - K241769

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K241769
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	Response Ortho Solutions LLC 1875 W Woolbright Rd Boynton Beach, FL 33426 US Other 510(k) Applications for this Company
Contact	Sehmuz Isin Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2024
Decision Date	09/18/2024
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