UniSpace® TPLIF Cage

GUDID 08800308483275

CG MedTech Co.,Ltd.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800308483275
• NIH Device Record Key: 51feaadf-b958-47ed-89f5-b7b5a070c43d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSpace® TPLIF Cage
• Version Model Number: TU1015
• Company DUNS: 688811082
• Company Name: CG MedTech 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	08800308483275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252351

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2025-12-19
• Device Publish Date: 2025-12-11

On-Brand Devices [UniSpace® TPLIF Cage]

• 08800308499634: NP0932
• 08800308499627: NP0932
• 08800308499610: NP0932
• 08800308499603: NP0932
• 08800308499597: PL0020
• 08800308499580: PL0010
• 08800308499283: TU0280
• 08800308499276: TU0270
• 08800308499269: TU0260
• 08800308499252: TU0250
• 08800308499245: TU0240
• 08800308499238: TU0230
• 08800308499221: TU0220
• 08800308499214: TU0210
• 08800308499207: TU0200
• 08800308499191: TU0190
• 08800308499184: TU0180
• 08800308499177: TU0170
• 08800308499160: TU0160
• 08800308499153: TU0150
• 08800308499146: TU0140
• 08800308499139: TU0130
• 08800308499122: TU0120
• 08800308499115: TU0110
• 08800308499108: TU0100
• 08800308499092: TU0090
• 08800308499085: TU0080
• 08800308499078: TU0070
• 08800308499061: TU0060
• 08800308499054: TU0050
• 08800308499047: TU0040
• 08800308499030: TU0030
• 08800308499023: TU0020
• 08800308498347: NP0932
• 08800308498330: TU0010
• 08800308498323: TU1007
• 08800308485743: TU4116
• 08800308485736: TU4115
• 08800308485729: TU4114
• 08800308485712: TU4113
• 08800308485705: TU4112
• 08800308485699: TU4016
• 08800308485682: TU4015
• 08800308485675: TU4014
• 08800308485668: TU4013
• 08800308485651: TU4012
• 08800308485644: TU4011
• 08800308485637: TU4010
• 08800308485620: TU3916
• 08800308485613: TU3915