Name: Predicase
Price: 199 USD

K-number	K172269
Device name	FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
Applicant	Globus Medical, Inc.
Product code	PML
Device class	Class II
Decision date	Mar 27, 2018
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System

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FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System