FDA.reportPublic FDA data

UniSpace® TPLIF Cage

Primary DI
08800308499283
Brand
UniSpace® TPLIF Cage
Company
CG MedTech Co.,Ltd.
Model
TU0280
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252351000UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800308499283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800308499283088003084992838800308499283

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800037575166ANAX™ 5.5 SPINAL SYSTEMSF09612026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMSF09622026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMSF09632026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMSF09602026-09-04
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCTS02202026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCTS02402026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCTS02602026-08-19
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27
08800247359945UniSpace® TPLIF CageTU02202026-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827723AVENGERMedartis AGLXH2026-10-13
07630894827730AVENGERMedartis AGLXH2026-10-13
07630894827747AVENGERMedartis AGLXH2026-10-13
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
00724995225148NASTERIS CORPORATIONLXH2025-03-31
00196449010219A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
00196449012800A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
B0842002000400Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000410Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000420Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000430Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000440Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000450Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000460Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000470Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000480Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000490Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000500Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000600Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000610Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000620Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000630Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000640Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000650Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000660Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000670Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000680Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000690Keos Lumbar InstrumentKEOSLXH2023-02-07