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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 / August 2026 / K262639

510(k) cleared

BAGUERA® C Cervical Disc Surgical Instruments

Spineart SA · Aug 14, 2026 · K262639

FDA cleared the BAGUERA® C Cervical Disc Surgical Instruments from Spineart SA on Aug 14, 2026 under K262639, a traditional 510(k). The device falls under product code QLQ, Manual Instruments Designed For Use With Total Disc Replacement Devices, regulated at 21 CFR 888.4515 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 29, 2026. The decision came 16 days later, inside the 90 FDA-day goal for a 510(k).

Spineart SA has 4 other decisions in the tracker over the last 12 months: P250042 (BAGUERA®C Cervical Disc Prosthesis), K261205 (SPINEART Navigation Instrument System), K253966 (PERLA® TL Posterior Thoraco-lumbar Fixation System), K254158 (SPINEART Navigation Instrument System).

Questions & Answers

What did FDA clear under K262639?

K262639 is the FDA 510(k) for BAGUERA® C Cervical Disc Surgical Instruments, submitted by Spineart SA. FDA's decision date was Aug 14, 2026, under product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices).

Who makes the BAGUERA® C Cervical Disc Surgical Instruments?

Spineart SA, based in Plan-Les-Ouates, is the applicant of record for K262639.

How long did the K262639 review take?

FDA received the submission on Jul 29, 2026 and issued its decision on Aug 14, 2026, 16 days later.

← All decisions in August 2026

Sources