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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 K042761
Device Name WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact NOAH BARTSCH
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact NOAH BARTSCH
Regulation Number888.3030
Classification Product Code
KTT  
Date Received10/05/2004
Decision Date 11/17/2004
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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