FDA device listing
iFuse Granite Onyx Implant System,iFuse Granite Onyx Navigation Instruments(intended for use with Onyx Implant System…
FDA device listing 1312175776 · SI-BONE, Inc.
Key facts
| Proprietary names | iFuse Granite Onyx Implant System,iFuse Granite Onyx Navigation Instruments(intended for use with Onyx Implant System and ExcelsiusGPS System),iFuse Granite Onyx Navigation Instruments(intended for use with Onyx Implant System and Medtronic StealthStation System) |
|---|---|
| Owner/operator | SI-BONE, Inc. |
| Owner/operator number | 10029402 |
| Premarket submissions | K262067 |
| Product codes | NKB, OLO |
| Device names | NKB - Thoracolumbosacral Pedicle Screw System, OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560, 888.3070 |
| Review panels | Neurology, Orthopedic |
| Registered establishments | SI-BONE, INC. |
| Establishment registrations | 3007700286, 3021948057 |
| FEI numbers | 3007700286, 3021948057 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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