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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 / P250042

PMA approved

BAGUERA®C Cervical Disc Prosthesis

Spineart USA, Inc. · Aug 10, 2026 · P250042

FDA approved the BAGUERA®C Cervical Disc Prosthesis from Spineart USA, Inc. on Aug 10, 2026 under P250042, an original premarket approval. The device falls under product code MJO, Prosthesis, Intervertebral Disc as a Class 3 device. The review panel was Orthopedic.

FDA logged the submission as received on Oct 31, 2025. The decision came 283 days later.

Spineart USA, Inc. has 4 other decisions in the tracker over the last 12 months: K262639 (BAGUERA® C Cervical Disc Surgical Instruments), K261205 (SPINEART Navigation Instrument System), K253966 (PERLA® TL Posterior Thoraco-lumbar Fixation System), K254158 (SPINEART Navigation Instrument System).

Questions & Answers

What did FDA approve under P250042?

P250042 is the FDA PMA for BAGUERA®C Cervical Disc Prosthesis, submitted by Spineart USA, Inc.. FDA's decision date was Aug 10, 2026, under product code MJO (Prosthesis, Intervertebral Disc).

Who makes the BAGUERA®C Cervical Disc Prosthesis?

Spineart USA, Inc., based in Laguna Hills, CA, is the applicant of record for P250042.

How long did the P250042 review take?

FDA received the submission on Oct 31, 2025 and issued its decision on Aug 10, 2026, 283 days later.

← All decisions in August 2026

Sources