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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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K052917
FOIA Releasable 510(k) K052917
Device Name STRYKER COMPARTMENTAL KNEE SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact VIVIAN KELLY
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact VIVIAN KELLY
Regulation Number888.3560
Classification Product Code
NPJ  
Subsequent Product Codes
HRY   HSX   KRR  
Date Received10/17/2005
Decision Date 12/27/2005
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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