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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 uncemented acetabular component)
510(k) Number K843950
Device Name LINK CEMENTLESS SCREW-IN ACETABULAR CUP
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
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/09/1984
Decision Date 06/03/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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