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510(k) K021719

FORTITUDE CEMENT RESTRICTOR by Spinal Concepts, Inc. — Product Code JDK

Clearance Details

Decision
SESU ()
Decision Date
August 15, 2002
Date Received
May 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Cement Restrictor
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

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