K-number	K223806
Device name	VERTICALE® Triangular Fixation System
Applicant	Silony Medical GmbH
Product code	NKB
Device class	Class II
Decision date	Jul 6, 2023
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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VERTICALE® Triangular Fixation System

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