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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K131413
Device Name XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received05/16/2013
Decision Date 01/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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