IMPLANT G6620766 NP PARAL 6MMX17MMX16MM

IMPLANT G6620766 NP PARAL 6MMX17MMX16MM
Divergence® Anterior Cervical Fusion System - G6620766

A collection of sterile devices used to induce new spinal bone tissue that consists of a metallic spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the protein and resulting bone growth. The bone morphogenetic protein is placed on the carrier/scaffold which is inserted into the spinal fusion cage. The spinal fusion cage is implanted into the spine and new bone tissue is induced at the site of implantation. The device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD). This is a single-use device.

No Data Available

• Width: 17.0 Millimeter
• Angle: 0.0 degree
• Height: 6.0 Millimeter
• Depth: 16.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00643169337817

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