Globus Medical, Inc. · Class II · Cleared May 7, 2026
| K-number | K253739 |
| Device name | SCRIPT® Rods, CREO® Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline® System |
| Applicant | Globus Medical, Inc. |
| Product code | NKB |
| Device class | Class II |
| Decision date | May 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
SCRIPT™ Rods are patient-matched spinal rods manufactured from titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium-molybdenum. They are designed to work with previously cleared CREO™, REVERE®, REVERE® 4.5, and NuVasive Reline™ implant systems to provide spinal fixation and stabilization as an adjunct to fusion for treating degenerative disc disease, scoliosis, trauma, tumors, stenosis, and failed previous fusions in both adult and pediatric patients.
Subject implants have the same or similar technological characteristics as predicate devices including design, intended use, material composition, function, and range of sizes. The rods can be rigidly locked into various configurations with CREO™, REVERE®, and Reline™ components and may be used anteriorly or posteriorly.
Not stated in this summary.
Subject devices have been found to be substantially equivalent to the predicate devices (CREO™, REVERE®, REVERE® 4.5, and NuVasive Reline™ systems) with respect to technical characteristics, performance, and intended use. Verification and validation testing including cadaveric usability testing and non-clinical system and software verification demonstrated that SCRIPT™ Rods met performance requirements for bending and design specifications, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov