| Primary Device ID | 08800039838085 | 
| NIH Device Record Key | 0dafeb38-7b58-466f-b746-365378484d59 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AEON-C | 
| Version Model Number | A | 
| Catalog Number | CSAS.14160011 | 
| 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 | 
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | |
| Phone | +82313699470 | 
| info@huvexel.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08800039838085 [Primary] | 
| OVE | Intervertebral fusion device with integrated fixation, cervical | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
[08800039838085]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-01-06 | 
| Device Publish Date | 2019-12-29 | 
| 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 |