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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 Directory / Orthopedics & Spine

Orthopedics & Spine

Empirical Spine

San Carlos, CA · Series B · PMA approved

Empirical Spine makes LimiFlex, a tension band implanted after lumbar decompression to stabilize the segment without fusion. The device came out of Stanford Biodesign and has a 2009 CE mark.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jun 16, 26	K253374510(k)	LimiFlex® Dynamic Sagittal Tether Instrument Set	Empirical Spine	Orthopedic	SGL
Feb 12, 26	P220031PMA	LimiFlex Dynamic Sagittal Tether	Empirical Spine, Inc.	Orthopedic	SGK

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Empirical Spine

FDA DECISIONS ON FILE

COVERAGE