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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 K051098
Device Name PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact LAURA D WILLIAMS
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact LAURA D WILLIAMS
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received04/29/2005
Decision Date 07/07/2005
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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