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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 K152841
Device Name Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
Applicant
ZIMMER, INC.
P.O BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact DOROTHY SNYDER
Correspondent
ZIMMER, INC.
P.O BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact DOROTHY SNYDER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/29/2015
Decision Date 11/24/2015
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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