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 / November 2025 / K250599

510(k) cleared

ExcelsiusGPS Instruments

Globus Medical, Inc. · Nov 5, 2025 · K250599

FDA cleared the ExcelsiusGPS Instruments from Globus Medical, Inc. on Nov 5, 2025 under K250599, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 28, 2025. The decision came 250 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K250599?

K250599 is the FDA 510(k) for ExcelsiusGPS Instruments, submitted by Globus Medical, Inc.. FDA's decision date was Nov 5, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the ExcelsiusGPS Instruments?

Globus Medical, Inc., based in Audubon, CA, is the applicant of record for K250599.

How long did the K250599 review take?

FDA received the submission on Feb 28, 2025 and issued its decision on Nov 5, 2025, 250 days later.

← All decisions in November 2025