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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K012172
Device Name DURACON PS LIPPED TIBIAL INSERT
Applicant
HOWMEDICA OSTEONICS
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Applicant Contact MARY-CATHERINE DILLON
Correspondent
HOWMEDICA OSTEONICS
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Correspondent Contact MARY-CATHERINE DILLON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/12/2001
Decision Date 10/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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