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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 K010839
Device Name CLS VARUS STEM/CLS 135 STEM
Applicant
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact BRUCE WALDON
Correspondent
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact BRUCE WALDON
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/21/2001
Decision Date 04/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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