FDA 510(k) Application Details - K190598

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K190598
Device Name	Arthroscope
Applicant	Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 US Other 510(k) Applications for this Company
Contact	Kelly J. Baker Other 510(k) Applications for this Contact
Regulation Number	888.1100   More FDA Info for this Regulation Number
Classification Product Code	HRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2019
Decision Date	04/05/2019
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