K-number	K181837
Device name	Spinal Elements Ti-Bond coated devices
Applicant	Spinal Elements, Inc.
Product code	MAX
Device class	Class II
Decision date	Nov 2, 2018
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Spinal Elements Ti-Bond coated devices

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