UniSpace® Stand-Alone C Cage

GUDID 08800308499511

CG MedTech Co.,Ltd.

Spinal implant trial

• Primary Device ID: 08800308499511
• NIH Device Record Key: 080683b4-96cd-4afd-867a-9fbd6f23aa47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSpace® Stand-Alone C Cage
• Version Model Number: AU130708
• Company DUNS: 688811082
• Company Name: CG MedTech Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	08800308499511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234119

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

[08800308499511]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-19
• Device Publish Date: 2025-12-11

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

• 08800247357149: AU0100
• 08800247357132: AU0090
• 08800037598660: AUS1025
• 08800037598653: AUS1024
• 08800037598646: AUS1023
• 08800037598639: AUS1022
• 08800037598622: AUS1021
• 08800037598615: AUS1020
• 08800037598608: AUS1019
• 08800037598592: AUS1018
• 08800037598585: AUS1017
• 08800037598578: AUS1016
• 08800037598561: AUS1015
• 08800308476895: AUS0120
• 08800308499573: AU230910
• 08800308499566: AU230708
• 08800308499559: AU220910
• 08800308499542: AU220708
• 08800308499535: AU220506
• 08800308499528: AU130910
• 08800308499511: AU130708
• 08800308499504: AU130506
• 08800308499498: AU120910
• 08800308499481: AU120708
• 08800308499474: AU120506
• 08800308499467: AU0190
• 08800308499450: AU0180
• 08800308499443: AU0170
• 08800308499436: AU0160
• 08800308499429: AU0140
• 08800308499412: AU0130
• 08800308499405: AU0120
• 08800308499399: AU0110
• 08800308499382: AU0100
• 08800308499375: AU0090
• 08800308499368: AU0080
• 08800308499351: AU0040
• 08800308499344: AU0035
• 08800308499337: AU0030
• 08800308499320: AU0025
• 08800308499313: AU0020
• 08800308499306: AU0010