# Isomedix Operations Inc. (contract sterilizer, Sandy, UT): 13 new FDA device listings, incl. plate, fixation, bone

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Isomedix Operations Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Sandy, UT, US |
| New listings | 13 |
| Devices | Plate, Fixation, Bone; Screw, Fixation, Bone; Washer, Bolt Nut; Left Atrial Appendage Clip, Implantable; Air-Handling Apparatus Accessory; Drills, Burrs, Trephines & Accessories (Manual); Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Product codes | HRS, HWC, HTN, PZX, QGI, HBG, HBE |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery, Neurology |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-10-15 |
| FDA registration number | 1720929 |
| Registration expires | 2027-12-31 |

## 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.
- Listed in the last 45 days.

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.