FDA device listing
FIXED TRACKER – BLUE,FIXED TRACKER – GOLD,FIXED TRACKER – GREEN,FIXED TRACKER – PURPLE,FIXED TRACKER SCREWDRIVER,FIXED…
FDA device listing 1147859972 · SI-BONE, Inc.
Key facts
| Proprietary names | FIXED TRACKER – BLUE,FIXED TRACKER – GOLD,FIXED TRACKER – GREEN,FIXED TRACKER – PURPLE,FIXED TRACKER SCREWDRIVER,FIXED TRACKER SET,ROTATING TRACKER - GREEN,ROTATING TRACKER - GREY,ROTATING TRACKER - ORANGE,ROTATING TRACKER SET,ROTATING TRACKER - VIOLET,Universal Pin Guide |
|---|---|
| Owner/operator | SI-BONE, Inc. |
| Owner/operator number | 10029402 |
| Premarket submissions | K232800 |
| Product codes | OLO |
| Device names | OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | Neurology |
| 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
- 10–99 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