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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
510(k) Number K150028
Device Name Zimmer Segmental System XT Components
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact KEITH J. PROCTOR
Correspondent
ZIMMER, INC./ ZIMMER, K.K.
PO BOX 708
WARSAW,  IN  46581
Correspondent Contact YORIKO KOBAYASHI
Regulation Number888.3510
Classification Product Code
KRO  
Date Received01/07/2015
Decision Date 02/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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