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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
510(k) Number K222978
Device Name Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Applicant
Xiros, Ltd.
Springfield House Ln., Whitehouse Ln.
Leeds,  GB LS17 7UE
Applicant Contact Steve Curran
Correspondent
Xiros, Ltd.
Springfield House Ln., Whitehouse Ln.
Leeds,  GB LS17 7UE
Correspondent Contact Steve Curran
Regulation Number878.3300
Classification Product Code
QUW  
Subsequent Product Codes
FTL   OWX  
Date Received09/28/2022
Decision Date 12/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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