K-number	K192434
Device name	DualX Lumbar Intervertebral Body Fusion Device
Applicant	Amplify Surgical, Inc.
Product code	MAX
Device class	Class II
Decision date	Oct 15, 2019
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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DualX Lumbar Intervertebral Body Fusion Device

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