FDA 510(k) Application Details - K200066

Device Classification Name	More FDA Info for this Device
510(K) Number	K200066
Device Name	Posterior Fusion Plate, HA Posterior Fusion Plate
Applicant	Spinal Simplicity LLC 6600 College Blvd, Ste 220 Overland Park, KS 66211 US Other 510(k) Applications for this Company
Contact	Adam Rogers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2020
Decision Date	12/10/2020
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