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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
Recalls CDRH Recalls
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