# Sterigenics US, LLC (contract sterilizer, Lewis Center, OH): 38 new FDA device listings, incl. injector and syringe, angiographic

**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 | Lewis Center, OH, US |
| New listings | 38 |
| Devices | Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic; Orthopedic Augmented Reality; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
| Product codes | DXT, IZQ, SBF, MBL, LPH, OQG, LZO, KRO, JDI, NRA, MAX, KWZ, MEH, LWJ, KWY |
| Device classes | Class II, Class III |
| Medical specialties | Cardiovascular, Neurology, Orthopedic |
| Brand names | MEDRAD® Centargo Day Set (CENT-DS); Zimmer Biomet OSS Orthopedic Salvage System OsseoTi Sleeves and Augments; Oxford Vivacit-E Bearings; Symmetrix™ L Spinal System; Z1 Hip System; CD Horizon™ ModuLeX™ FNS Screw Set with nanoLOCK™; CD Horizon™ ModuLeX™ Spinal System with nanoLOCK™; Screws and Navigated Instruments |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-08-26 |
| FDA registration number | 1526534 |
| 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: 2026-10-28T20:51:27.468Z.
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.