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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 / December 2025 / K253373

510(k) cleared

Southern Craniomaxillofacial (CMF) System

Southern Medical (Pty) , Ltd. · Dec 19, 2025 · K253373

FDA cleared the Southern Craniomaxillofacial (CMF) System from Southern Medical (Pty) , Ltd. on Dec 19, 2025 under K253373, a traditional 510(k). The device falls under product code JEY, Plate, Bone, regulated at 21 CFR 872.4760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2025. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Southern Medical (Pty) , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253373?

K253373 is the FDA 510(k) for Southern Craniomaxillofacial (CMF) System, submitted by Southern Medical (Pty) , Ltd.. FDA's decision date was Dec 19, 2025, under product code JEY (Plate, Bone).

Who makes the Southern Craniomaxillofacial (CMF) System?

Southern Medical (Pty) , Ltd., based in Irene, is the applicant of record for K253373.

How long did the K253373 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 19, 2025, 80 days later.

← All decisions in December 2025