FDA 510(k), K191100, ExcelsiusGPS Spine 1.1 Interbody Module

510(K) Number: K191100
Device Name: ExcelsiusGPS Spine 1.1 Interbody Module
Manufacturer: Globus Medical Inc.
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 04/25/2019
Decision Date: 07/24/2019
Regulation Medical Specialty: Neurology

Total pages: 757
Fully redacted pages: 545
Content pages: 212