K-number	K232521
Device name	ExactechGPS® Total Ankle Application
Applicant	Blue Ortho
Product code	OLO
Device class	Class II
Decision date	Nov 16, 2023
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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ExactechGPS® Total Ankle Application

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