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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 / February 2026 / P250028

PMA approved

Synergy Disc

Synergy Spine Solutions, Inc. · Feb 26, 2026 · P250028 · In the directory

FDA approved the Synergy Disc from Synergy Spine Solutions, Inc. on Feb 26, 2026 under P250028, 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 Jul 31, 2025. The decision came 210 days later.

Synergy Spine Solutions, Inc. has one other decision in the tracker over the last 12 months: K253392 (Synergy Disc Instruments).

Questions & Answers

What did FDA approve under P250028?

P250028 is the FDA PMA for Synergy Disc, submitted by Synergy Spine Solutions, Inc.. FDA's decision date was Feb 26, 2026, under product code MJO (Prosthesis, Intervertebral Disc).

Who makes the Synergy Disc?

Synergy Spine Solutions, Inc., based in Louisville, CO, is the applicant of record for P250028. The company is listed in the MedDevice Startups directory.

How long did the P250028 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Feb 26, 2026, 210 days later.

← All decisions in February 2026

Sources

In the startup directory

Synergy Spine Solutions

Orthopedics & Spine · Louisville, CO