510(k) K051836

SKELITE RESORBABLE CEMENT RESTRICTOR by Millenium Biologix, Inc. — Product Code JDK

Clearance Details

Decision
SESU ()
Decision Date
November 21, 2005
Date Received
July 6, 2005
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