K-number	K190881
Device name	Spinal Elements Navigated Instruments
Applicant	Spinal Elements, Inc.
Product code	OLO
Device class	Class II
Decision date	Dec 19, 2019
Decision	Substantially Equivalent
Regulation	882.4560

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View the full FDA submission: accessdata.fda.gov

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Spinal Elements Navigated Instruments

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