K-number	K061400
Device name	CALCANEAL TRAUMA SYSTEM
Applicant	Orthohelix Surgical Designs, Inc.
Product code	HRS
Device class	Class II
Decision date	Jun 29, 2006
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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CALCANEAL TRAUMA SYSTEM

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