SPACER 46511210 MD TI 12DG 37X29X10MM

SPACER 46511210 MD TI 12DG 37X29X10MM
Anteralign Spinal System with Titan nanoLock Surface technology - 46511210

A sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion.

No Data Available

No Data Available

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

Code: OVD

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Device Class: 2

Physical State: Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.

Definition: Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

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; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.

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: 00763000198343

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