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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, Porous Uncemented
510(k) Number K990849
Device Name DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
Applicant
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Applicant Contact MARYBETH NAUGHTON
Correspondent
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Correspondent Contact MARYBETH NAUGHTON
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received03/15/1999
Decision Date 12/20/1999
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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