510(k) K052367

SCIENT'X CEMENT RESTRICTOR by Scient'X — Product Code JDK

Clearance Details

Decision
SESU ()
Decision Date
October 5, 2005
Date Received
August 29, 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