CDH 7195525 HA COATED CANN 5.5X25


Product Overview

CDH 7195525 HA COATED CANN 5.5X25
CD HORIZON® Spinal System - 7195525


Device Description

An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 25.0 Millimeter
  • Outer Diameter: 5.5 Millimeter
    • Length: 25.0 Millimeter
    • Outer Diameter: 5.5 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    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: 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


    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: 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: 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


    Device Identifiers

    Device Id: 00885074355467

    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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