15 Deg Bayonetted Awl Guide, 2.0mm


Product Overview

15 Deg Bayonetted Awl Guide, 2.0mm
ENDOSKELETON® TCS - 5210-1073


Device Description

A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 2 Millimeter
  • Length: 10 Inch
    • Outer Diameter: 2 Millimeter
    • Length: 10 Inch


    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: ODP

    Device Name: Intervertebral Fusion Device With Bone Graft, Cervical

    Device Class: 2

    Physical State: Hollow cylinder or rectangular box made of metal or polymer.

    Definition: Intended to stabilize cervical 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


    Code: OVE

    Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical

    Device Class: 2

    Physical State: Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.

    Definition: Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

    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; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.

    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


    Code: LXH

    Device Name: Orthopedic Manual Surgical Instrument

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 888.4540

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00191375030775

    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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