FDA 510(k) Application Details - K212428

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K212428
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Diamond Wallace Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2021
Decision Date	12/13/2021
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