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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
Recalls CDRH Recalls
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