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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 K974556
Device Name OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
Applicant
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Applicant Contact DONNA S WILSON
Correspondent
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Correspondent Contact DONNA S WILSON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/05/1997
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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