IVA Cage Ti TTI.28090012

GUDID 08809557208547

Transforaminal Lumbar Interbody Fusion Straight Titanium CageL28 x W09 x H12 x A0

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08809557208547
• NIH Device Record Key: 010d51a3-cd3d-45ef-b0ec-ddf9ca1919a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVA Cage Ti
• Version Model Number: A
• Catalog Number: TTI.28090012
• 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
• 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 Dimensions

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
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• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809557208547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173080

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

[08809557208547]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-22
• Device Publish Date: 2018-06-19

On-Brand Devices [IVA Cage Ti]

• 08809557208486: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H15 x A8
• 08809557208479: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H14 x A8
• 08809557208462: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H13 x A8
• 08809557208455: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H12 x A8
• 08809557208448: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H11 x A8
• 08809557208431: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H10 x A8
• 08809557208424: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H9 x A8
• 08809557208417: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H8 x A8
• 08809557208400: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H7 x A8
• 08809557208394: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H15 x A4
• 08809557208387: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H14 x A4
• 08809557208370: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H13 x A4
• 08809557208363: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H12 x A4
• 08809557208356: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H11 x A4
• 08809557208349: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H10 x A4
• 08809557208332: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H9 x A4
• 08809557208325: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H8 x A4
• 08809557208318: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H7 x A4
• 08809557208301: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H15 x A8
• 08809557208295: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H14 x A8
• 08809557208288: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H13 x A8
• 08809557208271: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H12 x A8
• 08809557208264: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H11 x A8
• 08809557208257: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H10 x A8
• 08809557208240: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H9 x A8
• 08809557208233: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H8 x A8
• 08809557208226: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H7 x A8
• 08809557208219: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H15 x A4
• 08809557208202: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H14 x A4
• 08809557208196: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H13 x A4
• 08809557208189: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H12 x A4
• 08809557208172: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H11 x A4
• 08809557208165: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H10 x A4
• 08809557208158: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H9 x A4
• 08809557208141: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H8 x A4
• 08809557208134: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H7 x A4
• 08800039817912: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H16 x A8
• 08800039817905: Transforaminal Lumbar Interbody Fusion Curved Cage L36 x W9 x H16 x A4
• 08800039817899: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H16 x A8
• 08800039817882: Transforaminal Lumbar Interbody Fusion Curved Cage L32 x W9 x H16 x A4
• 08800039817875: Transforaminal Lumbar Interbody Fusion Curved Cage L28 x W9 x H16 x A8
• 08809557208837: Transforaminal Lumbar Interbody Fusion Curved Titanium CageL28 x W10 x H9 x A4
• 08809557208820: Transforaminal Lumbar Interbody Fusion Curved Titanium CageL28 x W10 x H8 x A4
• 08809557208813: Transforaminal Lumbar Interbody Fusion Curved Titanium CageL28 x W10 x H7 x A4
• 08809557208684: Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W09 x H16 x A0
• 08809557208677: Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W09 x H15 x A0
• 08809557208660: Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W09 x H14 x A0
• 08809557208653: Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W09 x H13 x A0
• 08809557208646: Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W09 x H12 x A0
• 08809557208639: Transforaminal Lumbar Interbody Fusion Straight Titanium CageL32 x W09 x H11 x A0