FDA 510(k)

UniSpace® TPLIF Cage

K-Number: K252351 · 2025-10-28

Decision Date2025-10-28

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UniSpace® TPLIF Cage is a medical device manufactured by Cg Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-28 under approval number K252351. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniSpace® TPLIF Cage?

UniSpace® TPLIF Cage is a medical device that received FDA 510(k) clearance on 2025-10-28. It is manufactured by Cg Medtech Co., Ltd.. The 510(k) number is K252351.

When was UniSpace® TPLIF Cage approved by the FDA?

UniSpace® TPLIF Cage received FDA 510(k) clearance on 2025-10-28, under approval number K252351.

What company makes UniSpace® TPLIF Cage?

UniSpace® TPLIF Cage is manufactured by Cg Medtech Co., Ltd..

What is the FDA product code for UniSpace® TPLIF Cage?

The FDA product code for UniSpace® TPLIF Cage is MAX.

Other Devices by Cg Medtech Co., Ltd.

K251725ANAX OCT Spinal System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.