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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 / December 2025 / K253876

510(k) cleared

HEDRON Cervical Spacers (HEDRON C-MIS Spacer)

Globus Medical, Inc. · Dec 22, 2025 · K253876

FDA cleared the HEDRON Cervical Spacers (HEDRON C-MIS Spacer) from Globus Medical, Inc. on Dec 22, 2025 under K253876, a special 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 4, 2025. The decision came 18 days later, inside the 90 FDA-day goal for a 510(k).

Globus Medical, Inc. has 7 other decisions in the tracker over the last 12 months: K254043 (TRIVANCE Hip Stem), K262251 (ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)), K253739 (SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System), K253401 (SCRIPT Implant System).

Questions & Answers

What did FDA clear under K253876?

K253876 is the FDA 510(k) for HEDRON Cervical Spacers (HEDRON C-MIS Spacer), submitted by Globus Medical, Inc.. FDA's decision date was Dec 22, 2025, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the HEDRON Cervical Spacers (HEDRON C-MIS Spacer)?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K253876.

How long did the K253876 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Dec 22, 2025, 18 days later.

← All decisions in December 2025