K-number	K152512
Device name	Half Dome Posterior Lumbar Interbody System
Applicant	Astura Medical
Product code	MAX
Device class	Class II
Decision date	Jan 28, 2016
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Half Dome Posterior Lumbar Interbody System

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