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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 / May 2026 / K253739

510(k) cleared

SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System

Globus Medical, Inc. · May 7, 2026 · K253739

FDA cleared the SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System from Globus Medical, Inc. on May 7, 2026 under K253739, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 24, 2025. The decision came 164 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)), K253401 (SCRIPT Implant System), K261043 (AUTOBAHN Nailing System).

Questions & Answers

What did FDA clear under K253739?

K253739 is the FDA 510(k) for SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System, submitted by Globus Medical, Inc.. FDA's decision date was May 7, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K253739.

How long did the K253739 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on May 7, 2026, 164 days later.

← All decisions in May 2026