# Sterigenics U.S. LLC (contract sterilizer, Mulberry, FL): 1 new FDA device listing, incl. fastener, fixation, nondegradable, soft tissue

**Score:** 65/100

| 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 | Mulberry, FL, US |
| New listings | 1 |
| Devices | Fastener, Fixation, Nondegradable, Soft Tissue |
| Product codes | MBI |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Infinity™ Large Tibial Button; Infinity™ Standard Tibial Button; Infinity™ Adjustable Loop Button Cradle; Infinity™ Femoral Adjustable Loop Button; Infinity™ Adjustable Free Loop |
| First new listing | 2026-06-04 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 1054811 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- 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.