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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 / K253392

510(k) cleared

Synergy Disc Instruments

Synergy Spine Solutions, Inc. · Mar 27, 2026 · K253392 · In the directory

FDA cleared the Synergy Disc Instruments from Synergy Spine Solutions, Inc. on Mar 27, 2026 under K253392, 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 Sep 30, 2025. The decision came 178 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Synergy Spine Solutions, Inc. has one other decision in the tracker over the last 12 months: P250028 (Synergy Disc).

Questions & Answers

What did FDA clear under K253392?

K253392 is the FDA 510(k) for Synergy Disc Instruments, submitted by Synergy Spine Solutions, Inc.. FDA's decision date was Mar 27, 2026, under product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices).

Who makes the Synergy Disc Instruments?

Synergy Spine Solutions, Inc., based in Louisville, CO, is the applicant of record for K253392. The company is listed in the MedDevice Startups directory.

How long did the K253392 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Mar 27, 2026, 178 days later.

← All decisions in March 2026

Sources

In the startup directory

Synergy Spine Solutions

Orthopedics & Spine · Louisville, CO