Bone graft substitute

Product Overview

Bone graft substitute
Vitoss BA Injectable - 2102-2301

Device Description

A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 20.00

  • Device Sizes

  • Total Volume: 1.2 Cubic Centimeter
    • Total Volume: 1.2 Cubic Centimeter

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: MQV

    Device Name: Filler, Bone Void, Calcium Compound

    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: 888.3045

    Third Party Flag: N

    Medical Specialty: OR

    Device Identifiers

    Device Id: 07613327064773

    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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