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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, uncemented
510(k) Number K963155
Device Name INTERMOORE FRACTURE HIP STEM (MODIFY)
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact JACKIE HUGHES
Correspondent
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact JACKIE HUGHES
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
JDI   KWL   KWY  
Date Received08/05/1996
Decision Date 10/01/1996
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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