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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K093846
Device Name LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact BENJAMIN CURSON
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact BENJAMIN CURSON
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH  
Date Received12/15/2009
Decision Date 02/04/2010
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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