WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K252351

510(k) cleared

UniSpace® TPLIF Cage

Cg Medtech Co., Ltd. · Oct 28, 2025 · K252351

FDA cleared the UniSpace® TPLIF Cage from Cg Medtech Co., Ltd. on Oct 28, 2025 under K252351, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 29, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Cg Medtech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252351?

K252351 is the FDA 510(k) for UniSpace® TPLIF Cage, submitted by Cg Medtech Co., Ltd.. FDA's decision date was Oct 28, 2025, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the UniSpace® TPLIF Cage?

Cg Medtech Co., Ltd., based in Uijeongbu-Si, is the applicant of record for K252351.

How long did the K252351 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Oct 28, 2025, 91 days later.

← All decisions in October 2025