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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K191053
Device Name Xtreme-Loop
Applicant
Xiros, Ltd.
Springfield House Ln., Whitehouse Ln.
Leeds,  GB LS17 7UE
Applicant Contact Stephen Seed
Correspondent
Xiros, Ltd.
Springfield House Ln., Whitehouse Ln.
Leeds,  GB LS17 7UE
Correspondent Contact Stephen Seed
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/19/2019
Decision Date 07/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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