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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/Polymer, Cemented
510(k) Number K955296
Device Name LINK MP RECONSTRUCTION HIP
Applicant
LINK AMERICA, INC.
6060 CASTLEWAY DR.
SUITE 236
INDIANAPOLIS,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
LINK AMERICA, INC.
6060 CASTLEWAY DR.
SUITE 236
INDIANAPOLIS,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
LWJ   LZO  
Date Received11/16/1995
Decision Date 02/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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