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PMA P970015S026

Device
LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
Applicant
Sofamor Danek
PMA number
P970015
Supplement
S026
Product code
MAX
Decision date
2004-04-16
Classification
Intervertebral Fusion Device With Bone Graft, Lumbar
Generic name
Intervertebral fusion device with bone graft, lumbar
Approval order statement
APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.

Current openFDA PMA Record#

Device
LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
Applicant
Sofamor Danek
PMA number
P970015
Supplement
S026
Product code
MAX
Generic name
Intervertebral fusion device with bone graft, lumbar
Decision date
2004-04-16
Decision code
APPR
Date received
2004-03-19
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.