CAGE 2964236 CAPSTONE-L 6 DEG 12X36

CAGE 2964236 CAPSTONE
CAPSTONE® L Spinal System - 2964236

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.

No Data Available

• 6 DEG, 12 MM X 36 MM

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00643169133037

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