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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 / March 2026 / K254176

510(k) cleared

SINEFIX

BAAT Medical Products B.V. · Mar 16, 2026 · K254176

FDA cleared the SINEFIX from BAAT Medical Products B.V. on Mar 16, 2026 under K254176, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 23, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

BAAT Medical Products B.V. has one other decision in the tracker over the last 12 months: K251961 (SDS Growing Rod).

Questions & Answers

What did FDA clear under K254176?

K254176 is the FDA 510(k) for SINEFIX, submitted by BAAT Medical Products B.V.. FDA's decision date was Mar 16, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the SINEFIX?

BAAT Medical Products B.V., based in Hengelo, is the applicant of record for K254176.

How long did the K254176 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Mar 16, 2026, 83 days later.

← All decisions in March 2026

Sources