AEON-C CSAT.15181513

GUDID 08800039836562

AEON-C Stand Alone; TAV; 15x18; 15deg; H13

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08800039836562
NIH Device Record Key262da9e2-8487-4279-89d2-2a1347d37224
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEON-C
Version Model NumberA
Catalog NumberCSAT.15181513
Company DUNS557795909
Company NameDIOMEDICAL CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039836562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

[08800039836562]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-06
Device Publish Date2019-12-29

On-Brand Devices [AEON-C]

088000398393964.2mm Bone Screw, Fixed, Self-Drilling, 26mm
088000398393894.2mm Bone Screw, Fixed, Self-Drilling, 24mm
088000398393724.2mm Bone Screw, Fixed, Self-Drilling, 22mm
088000398393654.2mm Bone Screw, Fixed, Self-Drilling, 20mm
088000398393584.2mm Bone Screw, Fixed, Self-Drilling, 18mm
088000398393414.2mm Bone Screw, Fixed, Self-Drilling, 16mm
088000398393344.2mm Bone Screw, Fixed, Self-Drilling, 14mm
088000398393274.2mm Bone Screw, Fixed, Self-Drilling, 12mm
088000398393104.2mm Bone Screw, Fixed, Self-Drilling, 10mm
088000398393034.2mm Bone Screw, Fixed, Self-Tapping, 26mm
088000398392974.2mm Bone Screw, Fixed, Self-Tapping, 24mm
088000398392804.2mm Bone Screw, Fixed, Self-Tapping, 22mm
088000398392734.2mm Bone Screw, Fixed, Self-Tapping, 20mm
088000398392664.2mm Bone Screw, Fixed, Self-Tapping, 18mm
088000398392594.2mm Bone Screw, Fixed, Self-Tapping, 16mm
088000398392424.2mm Bone Screw, Fixed, Self-Tapping, 14mm
088000398392354.2mm Bone Screw, Fixed, Self-Tapping, 12mm
088000398392284.2mm Bone Screw, Fixed, Self-Tapping, 10mm
088000398392114.2mm Bone Screw, Variable, Self-Drilling, 26mm
088000398392044.2mm Bone Screw, Variable, Self-Drilling, 24mm
088000398391984.2mm Bone Screw, Variable, Self-Drilling, 22mm
088000398391814.2mm Bone Screw, Variable, Self-Drilling, 20mm
088000398391744.2mm Bone Screw, Variable, Self-Drilling, 18mm
088000398391674.2mm Bone Screw, Variable, Self-Drilling, 16mm
088000398391504.2mm Bone Screw, Variable, Self-Drilling, 14mm
088000398391434.2mm Bone Screw, Variable, Self-Drilling, 12mm
088000398391364.2mm Bone Screw, Variable, Self-Drilling, 10mm
088000398391294.2mm Bone Screw, Variable, Self-Tapping, 26mm
088000398391124.2mm Bone Screw, Variable, Self-Tapping, 24mm
088000398391054.2mm Bone Screw, Variable, Self-Tapping, 22mm
088000398390994.2mm Bone Screw, Variable, Self-Tapping, 20mm
088000398390824.2mm Bone Screw, Variable, Self-Tapping, 18mm
088000398390754.2mm Bone Screw, Variable, Self-Tapping, 16mm
088000398390684.2mm Bone Screw, Variable, Self-Tapping, 14mm
088000398390514.2mm Bone Screw, Variable, Self-Tapping, 12mm
088000398390444.2mm Bone Screw, Variable, Self-Tapping, 10mm
088000398390373.6mm Bone Screw, Fixed, Self-Drilling, 26mm
088000398390203.6mm Bone Screw, Fixed, Self-Drilling, 24mm
088000398390133.6mm Bone Screw, Fixed, Self-Drilling, 22mm
088000398390063.6mm Bone Screw, Fixed, Self-Drilling, 20mm
088000398389933.6mm Bone Screw, Fixed, Self-Drilling, 18mm
088000398389863.6mm Bone Screw, Fixed, Self-Drilling, 16mm
088000398389793.6mm Bone Screw, Fixed, Self-Drilling, 14mm
088000398389623.6mm Bone Screw, Fixed, Self-Drilling, 12mm
088000398389553.6mm Bone Screw, Fixed, Self-Drilling, 10mm
088000398389483.6mm Bone Screw, Fixed, Self-Tapping, 26mm
088000398389313.6mm Bone Screw, Fixed, Self-Tapping, 24mm
088000398389243.6mm Bone Screw, Fixed, Self-Tapping, 22mm
088000398389173.6mm Bone Screw, Fixed, Self-Tapping, 20mm
088000398389003.6mm Bone Screw, Fixed, Self-Tapping, 18mm
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