K-number	K233593
Device name	MAGEC Spinal Bracing and Distraction System
Applicant	Nuvasive Specialized Orthopedics, Incorporated
Product code	PGN
Device class	Class II
Decision date	Feb 6, 2024
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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MAGEC Spinal Bracing and Distraction System

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