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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 / April 2026 / K253401

510(k) cleared

SCRIPT Implant System

Globus Medical, Inc. · Apr 29, 2026 · K253401

FDA cleared the SCRIPT Implant System from Globus Medical, Inc. on Apr 29, 2026 under K253401, a traditional 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 211 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), K261043 (AUTOBAHN Nailing System).

Questions & Answers

What did FDA clear under K253401?

K253401 is the FDA 510(k) for SCRIPT Implant System, submitted by Globus Medical, Inc.. FDA's decision date was Apr 29, 2026, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the SCRIPT Implant System?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K253401.

How long did the K253401 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Apr 29, 2026, 211 days later.

← All decisions in April 2026