K-number	K162391
Device name	AlignMATE Lapidus Arthrodesis System
Applicant	Arthrosurface, Inc.
Product code	HRS
Device class	Class II
Decision date	Feb 21, 2017
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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AlignMATE Lapidus Arthrodesis System

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AlignMATE Lapidus Arthrodesis System