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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 / November 2025 / K250769

510(k) cleared

Dakota LP System

Precision Spine, Inc. · Nov 24, 2025 · K250769

FDA cleared the Dakota LP System from Precision Spine, Inc. on Nov 24, 2025 under K250769, a traditional 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 13, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Precision Spine, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250769?

K250769 is the FDA 510(k) for Dakota LP System, submitted by Precision Spine, Inc.. FDA's decision date was Nov 24, 2025, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the Dakota LP System?

Precision Spine, Inc., based in Pear, MS, is the applicant of record for K250769.

How long did the K250769 review take?

FDA received the submission on Mar 13, 2025 and issued its decision on Nov 24, 2025, 256 days later.

← All decisions in November 2025