- Physicians Office Resource

CONNECTOR 811178GR 70MM TI 3.5MM ROD S
CD HORIZON® Growth Rod Conversion Set - 811178GR

Device Description

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Environmental Conditions

No Data Available

Device Sizes

DIA= 3.5mm L=70mm

DIA= 3.5mm L=70mm

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: 00643169500655

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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