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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 K964350
Device Name MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact SHAVAWN PARADUHN
Correspondent
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact SHAVAWN PARADUHN
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LZO  
Date Received10/31/1996
Decision Date 01/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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