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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 / May 2026 / K260850

510(k) cleared

OSTEOMNI SPINAL CAGES SYSTEM

Osteomni, Inc. · May 12, 2026 · K260850

FDA cleared the OSTEOMNI SPINAL CAGES SYSTEM from Osteomni, Inc. on May 12, 2026 under K260850, 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 16, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Osteomni, Inc. has one other decision in the tracker over the last 12 months: K254247 (OSTEOMNI SPINAL FIXATION SYSTEM).

Questions & Answers

What did FDA clear under K260850?

K260850 is the FDA 510(k) for OSTEOMNI SPINAL CAGES SYSTEM, submitted by Osteomni, Inc.. FDA's decision date was May 12, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the OSTEOMNI SPINAL CAGES SYSTEM?

Osteomni, Inc., based in Medley, FL, is the applicant of record for K260850.

How long did the K260850 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on May 12, 2026, 57 days later.

← All decisions in May 2026

Sources