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 / K253472

510(k) cleared

FIREFLY® Pedicle Screw Navigation Guide

Mighty Oak Medical · Feb 25, 2026 · K253472

FDA cleared the FIREFLY® Pedicle Screw Navigation Guide from Mighty Oak Medical on Feb 25, 2026 under K253472, a traditional 510(k). The device falls under product code PQC, Pedicle Screw Placement Guide, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Oct 10, 2025. The decision came 138 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mighty Oak Medical has 3 other decisions in the tracker over the last 12 months: K260322 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)), K252103 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)), K251532 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)).

Questions & Answers

What did FDA clear under K253472?

K253472 is the FDA 510(k) for FIREFLY® Pedicle Screw Navigation Guide, submitted by Mighty Oak Medical. FDA's decision date was Feb 25, 2026, under product code PQC (Pedicle Screw Placement Guide).

Who makes the FIREFLY® Pedicle Screw Navigation Guide?

Mighty Oak Medical, based in Englewood, CO, is the applicant of record for K253472.

How long did the K253472 review take?

FDA received the submission on Oct 10, 2025 and issued its decision on Feb 25, 2026, 138 days later.

← All decisions in February 2026

Sources