510(k) K060763

STRYKER INJECTABLE CEMENT by Stryker — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2006
Date Received
March 21, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type