# Steris Isomedix Puerto Rico, Inc. (contract sterilizer, Alts De Cerro Gordo 3&4, PR): 3 new FDA device listings, incl. thoracolumbosacral pedicle screw system

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Steris Isomedix Puerto Rico, Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Alts De Cerro Gordo 3&4, PR, US |
| New listings | 3 |
| Devices | Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body; Appliance, Fixation, Spinal Interlaminal |
| Product codes | NKB, KWQ, KWP |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| First new listing | 2026-05-06 |
| Latest new listing | 2026-05-06 |
| FDA registration number | 2648623 |
| 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.

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.