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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 K973837
Device Name CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
Applicant
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact SHAVAWN EVANS PARDUHN
Correspondent
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact SHAVAWN EVANS PARDUHN
Regulation Number888.3353
Classification Product Code
LZO  
Date Received10/08/1997
Decision Date 01/06/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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