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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 K170388
Device Name ANCHORMAN Tibial Ligament Fixation Device
Applicant
Summit Medical , Ltd.
Bourton Industrial Park
Bourton On The Water,  GB gl54 2hq
Applicant Contact Sam Drew
Correspondent
Summit Medical , Ltd.
Bourton Industrial Park
Bourton On The Water,  GB gl54 2hq
Correspondent Contact Sam Drew
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/08/2017
Decision Date 07/25/2017
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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