FDA 510(k) Application Details - K241563

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K241563
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	Extremity Medical, LLC 300 Interpace Parkway Building A, 2nd Floor Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Mary Hoffman 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	05/31/2024
Decision Date	02/21/2025
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