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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 K915222
Device Name WALKER HIP PROSTHESIS
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact CAROL VIERLING
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact CAROL VIERLING
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/20/1991
Decision Date 06/22/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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