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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, Porous Uncemented
510(k) Number K973714
Device Name VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
Applicant
ZIMMER, INC.
508 & 727 NORTH DETROIT ST.
WARSAW,  IN  46580
Applicant Contact KAREN CAIN
Correspondent
ZIMMER, INC.
508 & 727 NORTH DETROIT ST.
WARSAW,  IN  46580
Correspondent Contact KAREN CAIN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received09/29/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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