Name: Predicase
Price: 199 USD

K-number	K180156
Device name	SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Applicant	Globus Medical, Inc.
Product code	PEK
Device class	Class II
Decision date	Mar 7, 2018
Decision	Substantially Equivalent
Regulation	888.3050

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Source

View the full FDA submission: accessdata.fda.gov

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SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

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