K-number	K222903
Device name	Tailored-H Cervical Stand Alone System
Applicant	Bespoke Technologies, LLC
Product code	OVE
Device class	Class II
Decision date	Nov 18, 2022
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Tailored-H Cervical Stand Alone System

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