WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / February 2026 / K254247

510(k) cleared

OSTEOMNI SPINAL FIXATION SYSTEM

Osteomni, Inc. · Feb 24, 2026 · K254247

FDA cleared the OSTEOMNI SPINAL FIXATION SYSTEM from Osteomni, Inc. on Feb 24, 2026 under K254247, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 29, 2025. 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: K260850 (OSTEOMNI SPINAL CAGES SYSTEM).

Questions & Answers

What did FDA clear under K254247?

K254247 is the FDA 510(k) for OSTEOMNI SPINAL FIXATION SYSTEM, submitted by Osteomni, Inc.. FDA's decision date was Feb 24, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the OSTEOMNI SPINAL FIXATION SYSTEM?

Osteomni, Inc., based in Medley, FL, is the applicant of record for K254247.

How long did the K254247 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Feb 24, 2026, 57 days later.

← All decisions in February 2026

Sources