Sterigenics US LLC (contract sterilizer, Fort Worth, TX): 58 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
Sterigenics US LLC (Fort Worth, Texas): 58 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar. Its amount of 58 is top-decile (99th percentile of 2,570 records). Dated 77 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 58 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 58.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 67 related TX DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 | Fort Worth, TX, US |
| New listings | 58 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical; Spinal Vertebral Body Replacement Device; Mallet; Rongeur, Manual |
| Product codes | MAX, NKB, HSN, KDI, OVD, ODP, OVE, MQP, HXL, HAE, HRX, KWS, PHX, KSR, JDR |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, Gastroenterology, Urology, General, Plastic Surgery, Neurology, Hematology, General Hospital |
| Brand names | Tera-P; Janus HA Coated Fenestrated Screw; Salto Talaris Total Ankle Prosthesis; XT Revision Ankle Replacement System; Pillar SA Implant System; PTC Pillar SA Spacer Implant System; FORZA Titanium Spacer Implant System; Construx Mini Spacer Implant Spaces PEEK |
| First new listing | 2026-05-26 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 1649518 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 58.0x median) |
| Peer records CSV (68 TX records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-19
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (TX first): Sterigenics US LLC (contract sterilizer, Grand Prairie, TX) · Midwest Sterilization Corp. (contract sterilizer, Laredo, TX · Mlife Diagnostics LLC (contract manufacturer, Marshall, TX) · Gramercy Extremity Orthopedics, LLC. (manufacturer, Richards · Inspiration Medical Technology, Inc. (repackager or relabele · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Sterigenics US LLC and 68 Texas peers
- Texas DeviceEstablishmentPulse records like this one: 68
- Sterigenics US LLC's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $13,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Sterigenics US LLC in Fort Worth, Texas?
Sterigenics US LLC (Fort Worth, TX), a contract sterilizer, added 58 FDA device listings between 2026-05-26 and 2026-08-19.
How does Sterigenics US LLC compare to other Texas DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 58 is 58.0x the median of 1 across 2,570 records. It is 77 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Sterigenics US LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics US LLC | Fort Worth, TX | 58 | 99th | 2026-08-19 |
| Isomedix Operations Inc. | Whippany, NJ | 26 | 98th | 2026-09-28 |
| Isomedix Operations Inc. | S Plainfield, NJ | 16 | 96th | 2026-09-28 |
| Isomedix Operations Inc. | Sandy, UT | 13 | 95th | 2026-10-15 |
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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.