FDA 510(k) Application Details - K201457

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K201457
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	Auxein Medical Private Limited/71164 Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area Sonipath 131028 IN Other 510(k) Applications for this Company
Contact	Gaurav Luthra Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2020
Decision Date	04/06/2021
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