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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 / P220031

PMA approved

LimiFlex Dynamic Sagittal Tether

Empirical Spine, Inc. · Feb 12, 2026 · P220031 · In the directory

FDA approved the LimiFlex Dynamic Sagittal Tether from Empirical Spine, Inc. on Feb 12, 2026 under P220031, an original premarket approval. The device falls under product code SGK, Prosthesis, Spinous Process Tension Band Implant as a Class 3 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 19, 2022. The decision came 1151 days later.

Empirical Spine, Inc. has one other decision in the tracker over the last 12 months: K253374 (LimiFlex® Dynamic Sagittal Tether Instrument Set).

Questions & Answers

What did FDA approve under P220031?

P220031 is the FDA PMA for LimiFlex Dynamic Sagittal Tether, submitted by Empirical Spine, Inc.. FDA's decision date was Feb 12, 2026, under product code SGK (Prosthesis, Spinous Process Tension Band Implant).

Who makes the LimiFlex Dynamic Sagittal Tether?

Empirical Spine, Inc., based in Morgan Hill, CA, is the applicant of record for P220031. The company is listed in the MedDevice Startups directory.

How long did the P220031 review take?

FDA received the submission on Dec 19, 2022 and issued its decision on Feb 12, 2026, 1151 days later.

← All decisions in February 2026

Sources

In the startup directory

Empirical Spine

Orthopedics & Spine · San Carlos, CA