Locking Plate

Locking Plate
ENDOSKELETON® TCS Sterile Barrier System - 5303-1405-S

A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

No Data Available

• Compatible with all ENDOSKELETON® TCS interbody fusion devices

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: 00191375039976

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