FDA 510(k) Application Details - K240181

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K240181
Device Name	Plate, Fixation, Bone
Applicant	Auxein Medical Pvt. Ltd Auxein Medical Pvt. Ltd. Plot No. 168-169-170 Sector 57 Phase IV, HSIIDC Kundli Sonepat 131028 IN Other 510(k) Applications for this Company
Contact	Gaurav Luthra Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2024
Decision Date	10/09/2024
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