K-number	K132907
Device name	PLIF LITE AND TLIF LITE
Applicant	Sintea Plustek
Product code	MAX
Device class	Class II
Decision date	Jul 24, 2014
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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PLIF LITE AND TLIF LITE

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