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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 K111447
Device Name ZIMMER PERIARTICULAR SCREWS
Applicant
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact STEPHEN H MCKELVEY
Correspondent
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact STEPHEN H MCKELVEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/24/2011
Decision Date 10/05/2011
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
Recalls CDRH Recalls
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