510(k) K062348

TIMESH SELF DRILLING SCREW by Medtronic Neurosurgery — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2006
Date Received
August 11, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type