K-number	K221949
Device name	Ortho Device, ADAPTIX 3D Orthopedic Imaging System
Applicant	Pausch Medical GmbH
Product code	IZF
Device class	Class II
Decision date	Jan 26, 2023
Decision	Substantially Equivalent
Regulation	892.1740

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Source

View the full FDA submission: accessdata.fda.gov

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Ortho Device, ADAPTIX 3D Orthopedic Imaging System

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