PMA P960025S007

Device
LUMBAR I/F CAGE SYSTEM
Applicant
Depuy Spine, Inc.
PMA number
P960025
Supplement
S007
Product code
MCV
Decision date
2001-09-17
Classification
Spinal Pedicle Screw, Fixation, Appliance System
Generic name
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Approval order statement
APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT DEPUY ACROMED, RAYNHAM, MASSACHUSETTS.

Current openFDA PMA Record#

Device
LUMBAR I/F CAGE SYSTEM
Applicant
Depuy Spine, Inc.
PMA number
P960025
Supplement
S007
Product code
MCV
Generic name
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Decision date
2001-09-17
Decision code
APPR
Date received
2001-05-17
Supplement type
Normal 180 Day Track
Supplement reason
Express GMP Supplement
Approval order statement
APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT DEPUY ACROMED, RAYNHAM, MASSACHUSETTS.