K-number	K092721
Device name	ALIGN RADIAL HEAD SYSTEM
Applicant	Skeletal Dynamics, LLC
Product code	KWI
Device class	Class II
Decision date	Aug 3, 2010
Decision	Substantially Equivalent
Regulation	888.3170

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Source

View the full FDA submission: accessdata.fda.gov

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ALIGN RADIAL HEAD SYSTEM

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