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UniSpace® TPLIF Cage TU1015

by CG MedTech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800308483275 UDI-DI Date11 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
UniSpace® TPLIF Cage
Generic Name
Metallic spinal interbody fusion cage
Model / Reference
TU1015
Primary DI / UDI-DI
08800308483275
510(k) Number
FDA Product Code
MAX
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252351)

Show all (12)

Other devices from CG MedTech Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No