TL CAGE
ACCULIF - 305008
Device Description
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Environmental Conditions
No Data Available
Device Sizes
- Height: 10.0 Millimeter
- Length: 34.0 Millimeter
- Height: 8.0 Millimeter
- Angle: 0.0 degree
- Height: 9.0 Millimeter
- Width: 11.0 Millimeter
- Height: 12.0 Millimeter
- Height: 11.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MAX
Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class: 2
Physical State: hollow cylinder or rectangular box made of metal or polymer
Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Acts as a disc spacer and holds bone graft.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: intervertebral disc space
Regulation Number: 888.3080
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 07613327068054
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A