FDA 510(k) Application Details - K191169

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K191169
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Thao Huynh 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	05/01/2019
Decision Date	07/03/2019
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