Name: Predicase
Price: 199 USD

K-number	K211957
Device name	QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
Applicant	Globus Medical, Inc.
Product code	NKG
Device class	Class II
Decision date	Aug 18, 2021
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, Globus Navigation Instruments

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