IVA Cage CD.PI.0045

GUDID 08800039876766

Distractor H10

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800039876766
• NIH Device Record Key: bb0225b4-f093-4b13-a5b2-453bbdac91cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVA Cage
• Version Model Number: A
• Catalog Number: CD.PI.0045
• 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
• 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
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039876766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162220

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

[08800039876766]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [IVA Cage]

• 08800039872287: IVA TLIF(Bullet) CAGE L28xW09xA0xH17
• 08800039870573: TLIF Bullet Type Impactor
• 08800039870498: ACIF NC TRIAL L14XW16XA7XH11
• 08800039870481: ACIF NC TRIAL L14XW16XA7XH12
• 08800039870467: ALIF TRIAL L24xW35xA15xH17
• 08800039870450: ALIF TRIAL L24xW35xA15xH15
• 08800039870443: ALIF TRIAL L24xW35xA15xH13
• 08800039870436: ALIF TRIAL L24xW35xA15xH11
• 08800039870429: ALIF TRIAL L24xW35xA15xH9
• 08800039870412: ALIF TRIAL L24xW35xA8xH17
• 08800039870405: ALIF TRIAL L24xW35xA8xH15
• 08800039870399: ALIF TRIAL L24xW35xA8xH13
• 08800039870382: ALIF TRIAL L24xW35xA8xH11
• 08800039870375: ALIF TRIAL L24xW35xA8xH9
• 08800039870368: ALIF TRIAL L22xW29xA15xH17
• 08800039870351: ALIF TRIAL L22xW29xA15xH15
• 08800039870344: ALIF TRIAL L22xW29xA15xH13
• 08800039870337: ALIF TRIAL L22xW29xA15xH11
• 08800039870320: ALIF TRIAL L22xW29xA15xH9
• 08800039870313: ALIF TRIAL L22xW29xA8xH17
• 08800039870306: ALIF TRIAL L22xW29xA8xH15
• 08800039870290: ALIF TRIAL L22xW29xA8xH13
• 08800039870283: ALIF TRIAL L22xW29xA8xH11
• 08800039870276: ALIF TRIAL L22xW29xA8xH9
• 08800039842112: IVA Anterior Lumbar PEEK Straight Type 22*29*15*19
• 08800039842105: IVA Anterior Lumbar PEEK Straight Type 22*29*15*17
• 08800039842099: IVA Anterior Lumbar PEEK Straight Type 22*29*15*15
• 08800039842082: IVA Anterior Lumbar PEEK Straight Type 22*29*15*13
• 08800039842075: IVA Anterior Lumbar PEEK Straight Type 22*29*15*11
• 08800039842068: IVA Anterior Lumbar PEEK Straight Type 22*29*15*09
• 08800039842051: IVA Anterior Lumbar PEEK Straight Type 22*29*08*19
• 08800039842044: IVA Anterior Lumbar PEEK Straight Type 22*29*08*17
• 08800039842037: IVA Anterior Lumbar PEEK Straight Type 22*29*08*15
• 08800039842020: IVA Anterior Lumbar PEEK Straight Type 22*29*08*13
• 08800039842013: IVA Anterior Lumbar PEEK Straight Type 22*29*08*11
• 08800039842006: IVA Anterior Lumbar PEEK Straight Type 22*29*08*09
• 08800039834087: RASP 28X39 H21
• 08800039834070: RASP 28X39 H19
• 08800039834063: RASP 28X39 H17
• 08800039834056: RASP 28X39 H15
• 08800039834049: RASP 28X39 H13
• 08800039834032: RASP 28X39 H11
• 08800039834025: RASP 28X39 H9
• 08800039834018: RASP 24X35 H21
• 08800039834001: RASP 24X35 H19
• 08800039833998: RASP 24X35 H17
• 08800039833981: RASP 24X35 H15
• 08800039833974: RASP 24X35 H13
• 08800039833967: RASP 24X35 H11
• 08800039833950: RASP 24X35 H9