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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 / July 2026 / K251959

510(k) cleared

TnR Cranial Implant

T&R BIOFAB CO., Ltd. · Jul 30, 2026 · K251959

FDA cleared the TnR Cranial Implant from T&R BIOFAB CO., Ltd. on Jul 30, 2026 under K251959, a traditional 510(k). The device falls under product code GXP, Methyl Methacrylate For Cranioplasty, regulated at 21 CFR 882.5300 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 26, 2025. The decision came 399 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 T&R BIOFAB CO., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251959?

K251959 is the FDA 510(k) for TnR Cranial Implant, submitted by T&R BIOFAB CO., Ltd.. FDA's decision date was Jul 30, 2026, under product code GXP (Methyl Methacrylate For Cranioplasty).

Who makes the TnR Cranial Implant?

T&R BIOFAB CO., Ltd., based in Gyeonggi-Do, is the applicant of record for K251959.

How long did the K251959 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Jul 30, 2026, 399 days later.

← All decisions in July 2026