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FDA 510(k) K191100, ExcelsiusGPS Spine 1.1 Interbody Module, by Globus Medical, Inc.

FDA 510(k) K191100, ExcelsiusGPS Spine 1.1 Interbody Module, by Globus Medical, Inc.

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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

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