Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K-Number: K220091 · 2022-08-26
ApplicantXiros, Ltd.
Decision Date2022-08-26
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a medical device manufactured by Xiros, Ltd.. It received FDA 510(k) clearance on 2022-08-26 under approval number K220091. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Xiros, Ltd.. The 510(k) number is K220091.
When was Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device approved by the FDA?
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2022-08-26, under approval number K220091.
What company makes Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is manufactured by Xiros, Ltd..
What is the FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?
The FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is FTL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.