K-number	K242187
Device name	BioBrace®
Applicant	Conmed Corporation
Product code	OWW
Device class	Class II
Decision date	Nov 27, 2024
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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BioBrace®

Everything you need for a 510(k) submission. Nothing you don't.