AEON-C CSA.VD.4210

GUDID 08800039839136

4.2mm Bone Screw, Variable, Self-Drilling, 10mm

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800039839136
• NIH Device Record Key: 9d166f1a-5aed-45cd-bd50-5b5b8cc0c97a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEON-C
• Version Model Number: A
• Catalog Number: CSA.VD.4210
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039839136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191477

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

[08800039839136]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-29

On-Brand Devices [AEON-C]

• 08800039839396: 4.2mm Bone Screw, Fixed, Self-Drilling, 26mm
• 08800039839389: 4.2mm Bone Screw, Fixed, Self-Drilling, 24mm
• 08800039839372: 4.2mm Bone Screw, Fixed, Self-Drilling, 22mm
• 08800039839365: 4.2mm Bone Screw, Fixed, Self-Drilling, 20mm
• 08800039839358: 4.2mm Bone Screw, Fixed, Self-Drilling, 18mm
• 08800039839341: 4.2mm Bone Screw, Fixed, Self-Drilling, 16mm
• 08800039839334: 4.2mm Bone Screw, Fixed, Self-Drilling, 14mm
• 08800039839327: 4.2mm Bone Screw, Fixed, Self-Drilling, 12mm
• 08800039839310: 4.2mm Bone Screw, Fixed, Self-Drilling, 10mm
• 08800039839303: 4.2mm Bone Screw, Fixed, Self-Tapping, 26mm
• 08800039839297: 4.2mm Bone Screw, Fixed, Self-Tapping, 24mm
• 08800039839280: 4.2mm Bone Screw, Fixed, Self-Tapping, 22mm
• 08800039839273: 4.2mm Bone Screw, Fixed, Self-Tapping, 20mm
• 08800039839266: 4.2mm Bone Screw, Fixed, Self-Tapping, 18mm
• 08800039839259: 4.2mm Bone Screw, Fixed, Self-Tapping, 16mm
• 08800039839242: 4.2mm Bone Screw, Fixed, Self-Tapping, 14mm
• 08800039839235: 4.2mm Bone Screw, Fixed, Self-Tapping, 12mm
• 08800039839228: 4.2mm Bone Screw, Fixed, Self-Tapping, 10mm
• 08800039839211: 4.2mm Bone Screw, Variable, Self-Drilling, 26mm
• 08800039839204: 4.2mm Bone Screw, Variable, Self-Drilling, 24mm
• 08800039839198: 4.2mm Bone Screw, Variable, Self-Drilling, 22mm
• 08800039839181: 4.2mm Bone Screw, Variable, Self-Drilling, 20mm
• 08800039839174: 4.2mm Bone Screw, Variable, Self-Drilling, 18mm
• 08800039839167: 4.2mm Bone Screw, Variable, Self-Drilling, 16mm
• 08800039839150: 4.2mm Bone Screw, Variable, Self-Drilling, 14mm
• 08800039839143: 4.2mm Bone Screw, Variable, Self-Drilling, 12mm
• 08800039839136: 4.2mm Bone Screw, Variable, Self-Drilling, 10mm
• 08800039839129: 4.2mm Bone Screw, Variable, Self-Tapping, 26mm
• 08800039839112: 4.2mm Bone Screw, Variable, Self-Tapping, 24mm
• 08800039839105: 4.2mm Bone Screw, Variable, Self-Tapping, 22mm
• 08800039839099: 4.2mm Bone Screw, Variable, Self-Tapping, 20mm
• 08800039839082: 4.2mm Bone Screw, Variable, Self-Tapping, 18mm
• 08800039839075: 4.2mm Bone Screw, Variable, Self-Tapping, 16mm
• 08800039839068: 4.2mm Bone Screw, Variable, Self-Tapping, 14mm
• 08800039839051: 4.2mm Bone Screw, Variable, Self-Tapping, 12mm
• 08800039839044: 4.2mm Bone Screw, Variable, Self-Tapping, 10mm
• 08800039839037: 3.6mm Bone Screw, Fixed, Self-Drilling, 26mm
• 08800039839020: 3.6mm Bone Screw, Fixed, Self-Drilling, 24mm
• 08800039839013: 3.6mm Bone Screw, Fixed, Self-Drilling, 22mm
• 08800039839006: 3.6mm Bone Screw, Fixed, Self-Drilling, 20mm
• 08800039838993: 3.6mm Bone Screw, Fixed, Self-Drilling, 18mm
• 08800039838986: 3.6mm Bone Screw, Fixed, Self-Drilling, 16mm
• 08800039838979: 3.6mm Bone Screw, Fixed, Self-Drilling, 14mm
• 08800039838962: 3.6mm Bone Screw, Fixed, Self-Drilling, 12mm
• 08800039838955: 3.6mm Bone Screw, Fixed, Self-Drilling, 10mm
• 08800039838948: 3.6mm Bone Screw, Fixed, Self-Tapping, 26mm
• 08800039838931: 3.6mm Bone Screw, Fixed, Self-Tapping, 24mm
• 08800039838924: 3.6mm Bone Screw, Fixed, Self-Tapping, 22mm
• 08800039838917: 3.6mm Bone Screw, Fixed, Self-Tapping, 20mm
• 08800039838900: 3.6mm Bone Screw, Fixed, Self-Tapping, 18mm