K-number	K150670
Device name	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
Applicant	ETHICON, Inc.
Product code	NEW
Device class	Class II
Decision date	Jul 2, 2015
Decision	Substantially Equivalent
Regulation	878.4840

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View the full FDA submission: accessdata.fda.gov

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STRATAFIX Spiral PDS Plus Knotless Tissue Control Device

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