Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Mesh, Surgical, Polymeric

Xiros Ltd

The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Poly-tape/infinity-lock Soft Tissue Reinforcement Device.

Pre-market Notification Details

Device IDK220091
510k NumberK220091
Device Name:Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
ClassificationMesh, Surgical, Polymeric
Applicant Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds,  GB LS17 7UE
ContactSteve Curran
CorrespondentSteve Curran
Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds,  GB LS17 7UE
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-12
Decision Date2022-08-26

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