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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 K852705
Device Name LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
Applicant
Waldemar Link GmbH & Co. KG
10 Great Meadow Ln.
E. Hanover,  NJ  07936
Applicant Contact ED SCHUSSLER
Correspondent
Waldemar Link GmbH & Co. KG
10 Great Meadow Ln.
E. Hanover,  NJ  07936
Correspondent Contact ED SCHUSSLER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/26/1985
Decision Date 08/13/1985
Decision Substantially Equivalent (SESE)
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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