FDA device listing
Facet Fixx,Honour,Inertia,Struxxure
FDA device listing 1798588281 · Sotera Health LLC
Key facts
| Proprietary names | Facet Fixx,Honour,Inertia,Struxxure |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | KWP, KWQ, MAX, MNH, MNI, MQP, MRW, ODP |
| Device names | KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, MAX - Intervertebral Fusion Device With Bone Graft, Lumbar, MNH - Orthosis, Spondylolisthesis Spinal Fixation, MNI - Orthosis, Spinal Pedicle Fixation, MQP - Spinal Vertebral Body Replacement Device, MRW - System, Facet Screw Spinal Device, ODP - Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 888.3050, 888.3060, 888.3070, 888.3080, ORCA1.MRW |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics Radiation Technologies IN, Inc |
| Establishment registrations | 3009504230 |
| FEI numbers | 3009504230 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database