SET SCREW 7360000GR SS BREAK-OFF S

SET SCREW 7360000GR SS BREAK
CD HORIZON® Growth Rod Conversion Set - 7360000GR

Device Description

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PGM

Device Name: Growing Rod System

Device Class: 2

Physical State: Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories.

Definition: Stabilization or correction of spinal deformities without the use of fusion.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Pediatric spine.

Regulation Number: 888.3070

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 20643169545629

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