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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 / October 2025 / K253300

510(k) cleared

Fine Osteotomy

Bodycad Laboratories, Inc. · Oct 28, 2025 · K253300

FDA cleared the Fine Osteotomy from Bodycad Laboratories, Inc. on Oct 28, 2025 under K253300, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Bodycad Laboratories, Inc. has one other decision in the tracker over the last 12 months: K250394 (Fine TTO).

Questions & Answers

What did FDA clear under K253300?

K253300 is the FDA 510(k) for Fine Osteotomy, submitted by Bodycad Laboratories, Inc.. FDA's decision date was Oct 28, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the Fine Osteotomy?

Bodycad Laboratories, Inc., based in Quebec, is the applicant of record for K253300.

How long did the K253300 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Oct 28, 2025, 29 days later.

← All decisions in October 2025

Sources