FDA 510(k) Application Details - K211757

Device Classification Name	More FDA Info for this Device
510(K) Number	K211757
Device Name	Simplify Disc
Applicant	NuVasive, Inc. 685 North Pastoria Avenue Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Beth Neil Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2021
Decision Date	08/20/2021
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