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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

Synergy Spine Solutions

Louisville, CO · Series A · PMA approved

Synergy Spine Solutions makes the Synergy Disc, a cervical artificial disc with a lordotic core meant to restore alignment while preserving motion. It has sold outside the US since 2009.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 27, 26	K253392510(k)	Synergy Disc Instruments	Synergy Spine Solutions, Inc.	Orthopedic	QLQ
Feb 26, 26	P250028PMA	Synergy Disc	Synergy Spine Solutions, Inc.	Orthopedic	MJO

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Synergy Spine Solutions

FDA DECISIONS ON FILE

COVERAGE