K-number	K230689
Device name	T-FIX 3DSI Joint Fusion System
Applicant	Cutting Edge Spine, LLC
Product code	OUR
Device class	Class II
Decision date	Apr 5, 2023
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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T-FIX 3DSI Joint Fusion System

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T-FIX 3DSI Joint Fusion System