AVAMAX™ VERTEBRAL BALLOON TRAY 10GX10MM


Product Overview

AVAMAX™ VERTEBRAL BALLOON TRAY 10GX10MM
AVAmax - VBT1010


Device Description

A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • 0.00

  • Device Sizes

  • Length: 10 Millimeter
  • Needle Gauge: 10 Gauge
    • Length: 10 Millimeter
    • Needle Gauge: 10 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide


    Product Codes

    Code: HRX

    Device Name: Arthroscope

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    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: N

    Target Area: N/A

    Regulation Number: 888.1100

    Third Party Flag: Y

    Medical Specialty: OR


    Code: NDN

    Device Name: Cement, Bone, Vertebroplasty

    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: 888.3027

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 50885403119994

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403119996

    Package Quantity: 5

    Package Discontinue Date: 4/12/2018 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CS


    Device Id: 10885403119996

    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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