FDA 510(k) Application Details - K203678

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K203678
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Madhuvanthi Soundirarajan Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2020
Decision Date	01/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review