K-number	K080778
Device name	ENSPLINT TM BONE SCREW
Applicant	Sonoma Orthopedic Products, Inc.
Product code	HWC
Device class	Class II
Decision date	Jul 10, 2008
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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ENSPLINT TM BONE SCREW

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