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 the device name listed in this FDA 510(k) record. The listed applicant is Cg Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-28 under 510(k) 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. The listed applicant is Cg Medtech Co., Ltd.. The 510(k) number is K252351.

When did UniSpace® TPLIF Cage receive FDA 510(k) clearance?

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

Who is the listed applicant for UniSpace® TPLIF Cage?

The FDA 510(k) record lists Cg Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cg Medtech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.