# Sterigenics US LLC (contract sterilizer, Charlotte, NC): 16 new FDA device listings, incl. nail, fixation, bone

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics US LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Charlotte, NC, US |
| New listings | 16 |
| Devices | Nail, Fixation, Bone; Screw, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Knife, Surgical; Arthroscope; Intervertebral Fusion Device With Bone Graft, Lumbar; Staple, Fixation, Bone |
| Product codes | JDS, HWC, HSB, DXT, IZQ, KCT, EMF, HRX, MAX, JDR, OLO, OUR |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, Cardiovascular, General Hospital, General, Plastic Surgery, Neurology |
| Brand names | DynaNail TTC; MEDRAD® Centargo Day Set (CENT-DS); DynaNail Hybrid; LUX Expandable Lumbar Interbody System; Xenix Medical Sacroiliac Fixation System |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-07-10 |
| FDA registration number | 1058584 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-11-04T21:52:36.524Z.
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.