K-number	K140216
Device name	ORTHOPEDIC FIXATION SYSTEMS
Applicant	Impact Medical, LLC
Product code	HRS
Device class	Class II
Decision date	May 1, 2014
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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ORTHOPEDIC FIXATION SYSTEMS

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