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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 K973087
Device Name MOST HEX INTRAMEDULLARY (I/M) STEM
Applicant
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact MITCHELL A DHORITY
Correspondent
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact MITCHELL A DHORITY
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KRO  
Date Received08/18/1997
Decision Date 11/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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