# Sterigenics U.S. LLC (contract sterilizer, Hayward, CA): 6 new FDA device listings, incl. system, facet screw spinal device

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics U.S. LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Hayward, CA, US |
| New listings | 6 |
| Devices | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument; Magnetic Surgical System; Trabeculotome; Pump, Infusion, Ophthalmic |
| Product codes | MRW, OLO, PNL, HMZ, MRH |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Neurology, General, Plastic Surgery, Ophthalmic, General Hospital |
| Brand names | CORUS-LX Implant, 4mm; CORUS-LX LevelOne, 4mm; PCSS IMPLANT, 5MM; CORUS PCSS LEVELONE; PCSS IMPLANT, 4MM; CORUS-LX Implant, 5mm; CORUS Navigation Access-GLX; CAVUX Facet Fixation System, 4mm |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-05-07 |
| FDA registration number | 2953359 |
| 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.