FDA 510(k) Application Details - K221787

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K221787
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	Auxein Medical Private Limited Plot No. 168,169,170, Phase-IV, Sector 57 Kundli Industrial area Sonipat 131028 IN Other 510(k) Applications for this Company
Contact	Rahul Luthra 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	06/21/2022
Decision Date	11/30/2023
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