K-number	K201024
Device name	Expandable Titanium PLIF/TLIF System
Applicant	Spectrum Spine, LLC
Product code	MAX
Device class	Class II
Decision date	Apr 29, 2021
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Expandable Titanium PLIF/TLIF System

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