K-number	K192144
Device name	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
Applicant	ETHICON, Inc.
Product code	NEW
Device class	Class II
Decision date	Mar 25, 2020
Decision	Substantially Equivalent
Regulation	878.4840

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Source

View the full FDA submission: accessdata.fda.gov

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STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

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