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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, cemented
510(k) Number K960626
Device Name MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact JACQUELINE HUGHES
Correspondent
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact JACQUELINE HUGHES
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
KRO  
Date Received02/13/1996
Decision Date 04/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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