- Physicians Office Resource

IMPLANT G6626242 NP LORDO 12MMX20MMX14MM
Divergence® Anterior Cervical Fusion System - G6626242

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

Height: 12.0 Millimeter

Width: 20.0 Millimeter

Depth: 14.0 Millimeter

Angle: 6.0 degree

Height: 12.0 Millimeter
Width: 20.0 Millimeter
Depth: 14.0 Millimeter
Angle: 6.0 degree

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OVE

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical

Device Class: 2

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

Definition: Intended to stabilize cervical 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 Identifiers

Device Id: 00643169337572

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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