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510(k) K033953

OPTIMESH 500E CEMENT RESTRICTOR by Spineology, Inc. — Product Code JDK

Clearance Details

Decision
SESU ()
Decision Date
July 6, 2004
Date Received
December 22, 2003
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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