K-number	K183342
Device name	SambaScrew 3D SI Fusion System
Applicant	Orthofix, Inc.
Product code	OUR
Device class	Class II
Decision date	Apr 30, 2019
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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SambaScrew 3D SI Fusion System

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