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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 K981967
Device Name WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
Applicant
Arthrotek/Biomet, Inc.
Airport Industrial Park
Warsaw,  IN  46580
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Arthrotek/Biomet, Inc.
Airport Industrial Park
Warsaw,  IN  46580
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received06/04/1998
Decision Date 07/17/1998
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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