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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 / June 2026 / K253374

510(k) cleared

LimiFlex® Dynamic Sagittal Tether Instrument Set

Empirical Spine · Jun 16, 2026 · K253374 · In the directory

FDA cleared the LimiFlex® Dynamic Sagittal Tether Instrument Set from Empirical Spine on Jun 16, 2026 under K253374, a traditional 510(k). The device falls under product code SGL, Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant, regulated at 21 CFR 888.4520 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Empirical Spine has one other decision in the tracker over the last 12 months: P220031 (LimiFlex Dynamic Sagittal Tether).

Questions & Answers

What did FDA clear under K253374?

K253374 is the FDA 510(k) for LimiFlex® Dynamic Sagittal Tether Instrument Set, submitted by Empirical Spine. FDA's decision date was Jun 16, 2026, under product code SGL (Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant).

Who makes the LimiFlex® Dynamic Sagittal Tether Instrument Set?

Empirical Spine, based in Morgan Hill, CA, is the applicant of record for K253374. The company is listed in the MedDevice Startups directory.

How long did the K253374 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jun 16, 2026, 259 days later.

← All decisions in June 2026

Sources

In the startup directory

Empirical Spine

Orthopedics & Spine · San Carlos, CA