K-number	K222501
Device name	Regeneten Bioinductive Implant
Applicant	Smith and Nephew, Inc.
Product code	OWY
Device class	Class II
Decision date	May 11, 2023
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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Regeneten Bioinductive Implant

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