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 / December 2025 / K253118

510(k) cleared

Companion Spine DIAM Instrumentation

Companion Spine France · Dec 16, 2025 · K253118

FDA cleared the Companion Spine DIAM Instrumentation from Companion Spine France on Dec 16, 2025 under K253118, a traditional 510(k). The device falls under product code QLR, Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices, regulated at 21 CFR 888.4520 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 24, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

Companion Spine France has one other decision in the tracker over the last 12 months: P240043 (DIAM Spinal Stabilization System).

Questions & Answers

What did FDA clear under K253118?

K253118 is the FDA 510(k) for Companion Spine DIAM Instrumentation, submitted by Companion Spine France. FDA's decision date was Dec 16, 2025, under product code QLR (Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices).

Who makes the Companion Spine DIAM Instrumentation?

Companion Spine France, based in Mérignac, is the applicant of record for K253118.

How long did the K253118 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Dec 16, 2025, 83 days later.

← All decisions in December 2025

Sources