CAGE 2964840 CAPSTONE
CAPSTONE® L Spinal System - 2964840
Device Description
A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.
Environmental Conditions
No Data Available
Device Sizes
- 6 DEG, 8 MM X 40 MM
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: 00643169133181
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
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