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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K171680
Device Name Infinity-Lock 3, Infinity-Lock 5
Applicant
Xiros, Ltd.
Springfield House, Whitehouse Ln.,
Leeds,  GB LS19 7UE
Applicant Contact Stephen Seed
Correspondent
Xiros, Ltd.
Springfield House, Whitehouse Ln.,
Leeds,  GB LS19 7UE
Correspondent Contact Stephen Seed
Regulation Number878.5000
Classification Product Code
GAT  
Date Received06/06/2017
Decision Date 06/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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