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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K971523
Device Name DISTALLY FIXED HIP STEM
Applicant
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact SAM MIRZA
Correspondent
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact SAM MIRZA
Regulation Number888.3353
Classification Product Code
MEH  
Date Received04/28/1997
Decision Date 10/01/1997
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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