K-number	DEN180065
Device name	OGmend Implant System
Applicant	Woven Orthopedic Technologies, LLC
Product code	QAC
Device class	Class II
Decision date	May 1, 2020
Decision	Not Substantially Equivalent
Regulation	888.3043

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View the full FDA submission: accessdata.fda.gov

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OGmend Implant System

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