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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K080685
Device Name HIPLOC COMPRESSION HIP SCREW
Applicant
Biomet Manufacturing, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact BECKY EARL
Correspondent
Biomet Manufacturing, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact BECKY EARL
Regulation Number888.3030
Classification Product Code
JDO  
Subsequent Product Code
KTT  
Date Received03/11/2008
Decision Date 08/15/2008
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
Recalls CDRH Recalls
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