K-number	K192911
Device name	Brainlab Compatible K2M Navigation Instruments
Applicant	K2m, Inc.
Product code	OLO
Device class	Class II
Decision date	Nov 14, 2019
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Brainlab Compatible K2M Navigation Instruments

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