Name: Predicase
Price: 199 USD

K-number	K231850
Device name	QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
Applicant	Globus Medical, Inc.
Product code	NKG
Device class	Class II
Decision date	Mar 14, 2024
Decision	Substantially Equivalent
Regulation	888.3075

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Source

View the full FDA submission: accessdata.fda.gov

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QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments

Everything you need for a 510(k) submission. Nothing you don't.