PMA P950019S003

Device
RAY TFC DEVICE WITH INSTRUMENTATION (20MM)
Applicant
Stryker Spine
PMA number
P950019
Supplement
S003
Product code
MAX
Decision date
1998-06-17
Classification
Intervertebral Fusion Device With Bone Graft, Lumbar
Generic name
Intervertebral fusion device with bone graft, lumbar
Approval order statement
Approval for the addition of 20mm cages and modified labeling.

Current openFDA PMA Record#

Device
RAY TFC DEVICE WITH INSTRUMENTATION (20MM)
Applicant
Stryker Spine
PMA number
P950019
Supplement
S003
Product code
MAX
Generic name
Intervertebral fusion device with bone graft, lumbar
Decision date
1998-06-17
Decision code
APPR
Date received
1998-05-15
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of 20mm cages and modified labeling.