- Physicians Office Resource

MODULE 1665008 TAB EXTENDER MODULE
CD HORIZON Spinal System - 1665008

Device Description

A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Moist Heat or Steam Sterilization

Product Codes

Code: MNH

Device Name: Orthosis, Spondylolisthesis Spinal Fixation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3070

Third Party Flag: N

Medical Specialty: OR

Code: OSH

Device Name: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Device Class: 2

Physical State: Bone screws, rods, and hooks intended to stabilize the spine as an adjunct to fusion

Definition: Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Acts as a spinal fusion system with autograft and/or allograft to stabilize the spine as an adjunct to fusion to treat adolescent idiopathic scoliosis

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Posterior, non-cervical spinal column in adolescent patients

Regulation Number: 888.3070

Third Party Flag: N

Medical Specialty: OR

Code: MNI

Device Name: Orthosis, Spinal Pedicle Fixation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3070

Third Party Flag: N

Medical Specialty: OR

Code: NKB

Device Name: Thoracolumbosacral Pedicle Screw System

Device Class: 2

Physical State: N/A

Definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3070

Third Party Flag: N

Medical Specialty: OR

Code: KWP

Device Name: Appliance, Fixation, Spinal Interlaminal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3050

Third Party Flag: N

Medical Specialty: OR

Code: KWQ

Device Name: Appliance, Fixation, Spinal Intervertebral Body

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3060

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 00643169596320

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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