IVA Cage Ti TDI.60221011

GUDID 08800039810432

Lateral Lumbar Interbody Fusion Titanium CageL60 x W22 x H11 x A10

DIOMEDICAL CO.,LTD.

Metallic spinal fusion cage, non-sterile

Primary Device ID	08800039810432
NIH Device Record Key	94a8214e-c855-450e-9358-c3f8fbbfb002
Commercial Distribution Status	In Commercial Distribution
Brand Name	IVA Cage Ti
Version Model Number	A
Catalog Number	TDI.60221011
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

Device Dimensions

Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter
Height	11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039810432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173080

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

[08800039810432]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2023-12-18
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

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