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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Resorbable, Hard Tissue
510(k) Number K140625
FOIA Releasable 510(k) K140625
Device Name ORTHOSORB LS
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Applicant Contact VICTORIA SCHEITLIN
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact VICTORIA SCHEITLIN
Regulation Number888.3040
Classification Product Code
OVZ  
Date Received03/11/2014
Decision Date 04/18/2014
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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