INST KIT 9735158 SURETRAK II MED CLAMP


Product Overview

INST KIT 9735158 SURETRAK II MED CLAMP
N/A - 9735158


Device Description

An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.


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: MAX

    Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar

    Device Class: 2

    Physical State: hollow cylinder or rectangular box made of metal or polymer

    Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

    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.

    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 Identifiers

    Device Id: 00763000209612

    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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