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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K160058
Device Name Biomet Variable Pitch Compression Screw System
Applicant
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Julie Largent
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Julie Largent
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/12/2016
Decision Date 03/09/2016
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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