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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 K001320
Device Name SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
Applicant
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact FRANCES E HARRISON
Correspondent
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact FRANCES E HARRISON
Regulation Number888.3358
Classification Product Code
LPH  
Date Received04/26/2000
Decision Date 07/07/2000
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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