UniSpace® Stand-Alone C Cage

GUDID 08800247355756

Innosys Co., Ltd.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 08800247355756
• NIH Device Record Key: 86f0feb3-cf41-468f-9da3-0806984278a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSpace® Stand-Alone C Cage
• Version Model Number: AU4311
• 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: true
• 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	08800247355756 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-28
• Device Publish Date: 2024-06-20

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