# Globus Medical, Inc. (manufacturer, Audubon, PA): 16 new FDA device listings, incl. thoracolumbosacral pedicle screw system

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Globus Medical, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Audubon, PA, US |
| New listings | 16 |
| Devices | Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Growing Rod System; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Rod, Fixation, Intramedullary And Accessories; Screw, Fixation, Bone; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Product codes | NKB, KWP, PGM, OSH, HSB, HWC, JWH, OIY, MBH, LWJ, KWY, OQI, LPH, JDI, OQH |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | SCRIPT; PRECICE; ACTIFY 3D; TRIVANCE |
| First new listing | 2026-05-11 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 3004142400 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.