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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 / K252686

510(k) cleared

EffortMed PEEK Cages & Corpectomy Cages

Effortmed, LLC · Nov 21, 2025 · K252686

FDA cleared the EffortMed PEEK Cages & Corpectomy Cages from Effortmed, LLC on Nov 21, 2025 under K252686, 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 Aug 26, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Effortmed, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252686?

K252686 is the FDA 510(k) for EffortMed PEEK Cages & Corpectomy Cages, submitted by Effortmed, LLC. FDA's decision date was Nov 21, 2025, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the EffortMed PEEK Cages & Corpectomy Cages?

Effortmed, LLC, based in Coral Springs, FL, is the applicant of record for K252686.

How long did the K252686 review take?

FDA received the submission on Aug 26, 2025 and issued its decision on Nov 21, 2025, 87 days later.

← All decisions in November 2025