UniSpace® Stand-Alone C Cage

GUDID 08800247361559

Innosys Co., Ltd.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800247361559
• NIH Device Record Key: febcf286-a82a-4968-8ec8-d4333838af05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSpace® Stand-Alone C Cage
• Version Model Number: AU3512VT
• Company DUNS: 688811082
• Company Name: Innosys Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800247361559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234119

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

[08800247361559]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-13
• Device Publish Date: 2024-05-03

On-Brand Devices [UniSpace® Stand-Alone C Cage]

• 08800247361757: AUA1000
• 08800247361740: AU4020VT
• 08800247361733: AU4019VT
• 08800247361726: AU4018VT
• 08800247361719: AU4017VT
• 08800247361702: AU4016VT
• 08800247361696: AU4015VT
• 08800247361689: AU4014VT
• 08800247361672: AU4013VT
• 08800247361665: AU4012VT
• 08800247361658: AU4011VT
• 08800247361641: AU4010VT
• 08800247361634: AU3520VT
• 08800247361627: AU3519VT
• 08800247361610: AU3518VT
• 08800247361603: AU3517VT
• 08800247361597: AU3516VT
• 08800247361580: AU3515VT
• 08800247361573: AU3514VT
• 08800247361566: AU3513VT
• 08800247361559: AU3512VT
• 08800247361542: AU3511VT
• 08800247361535: AU3510VT
• 08800247361528: AU4020VD
• 08800247361511: AU4019VD
• 08800247361504: AU4018VD
• 08800247361498: AU4017VD
• 08800247361481: AU4016VD
• 08800247361474: AU4015VD
• 08800247361467: AU4014VD
• 08800247361450: AU4013VD
• 08800247361443: AU4012VD
• 08800247361436: AU4011VD
• 08800247361429: AU4010VD
• 08800247361412: AU3520VD
• 08800247361405: AU3519VD
• 08800247361399: AU3518VD
• 08800247361382: AU3517VD
• 08800247361375: AU3516VD
• 08800247361368: AU3515VD
• 08800247361351: AU3514VD
• 08800247361344: AU3513VD
• 08800247361337: AU3512VD
• 08800247361320: AU3511VD
• 08800247361313: AU3510VD
• 08800247361306: AU4412
• 08800247361290: AU4411
• 08800247361283: AU4410
• 08800247361276: AU4409
• 08800247361269: AU4312