PMA P960025S008

Device
LUMBAR I/F CAGE(R) SYSTEM
Applicant
Depuy Spine, Inc.
PMA number
P960025
Supplement
S008
Product code
MCV
Decision date
2002-03-01
Classification
Spinal Pedicle Screw, Fixation, Appliance System
Generic name
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Approval order statement
APPROVAL FOR A WEDGED VERSION OF THE I/F CAGE COMPONENT. THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.

Current openFDA PMA Record#

Device
LUMBAR I/F CAGE(R) SYSTEM
Applicant
Depuy Spine, Inc.
PMA number
P960025
Supplement
S008
Product code
MCV
Generic name
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Decision date
2002-03-01
Decision code
APPR
Date received
2001-09-04
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A WEDGED VERSION OF THE I/F CAGE COMPONENT. THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.