K-number	K220091
Device name	Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Applicant	Xiros, Ltd.
Product code	FTL
Device class	Class II
Decision date	Aug 26, 2022
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

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