- Physicians Office Resource

Interbody Fusion Device 6 Degree Large 7mm
ENDOSKELETON® TCS nanoLOCK® Surface Technology - 5386-1607-N

Device Description

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Environmental Conditions

No Data Available

Device Sizes

Depth: 16 Millimeter

Angle: 6 degree

width(MLxAP), 18 x 16, mm

Width: 18 Millimeter

Lordotic Angle 6 Deg

Height: 7 Millimeter

Depth: 16 Millimeter
Angle: 6 degree
width(MLxAP), 18 x 16, mm
Width: 18 Millimeter
Lordotic Angle 6 Deg
Height: 7 Millimeter

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: 00191375018544

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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