FDA device listing
11-Gauge Bone Access Needle,Adapter, Stealth Pin Guide,Adjustable Broach Stop,Adjustable Parallel Pin Guide,Blunt Pin…
FDA device listing 1748761216 · SI-BONE, Inc.
Key facts
| Proprietary names | 11-Gauge Bone Access Needle,Adapter, Stealth Pin Guide,Adjustable Broach Stop,Adjustable Parallel Pin Guide,Blunt Pin 2.0mm,Blunt Pin, 2.0mm,Blunt Pin 3.2mm,Blunt Pin, 3.2mm,Cannulated Impactor,Decorticator,Drill Sleeve Assembly,Drill Sleeve Assembly, 4.0mm,Exchange Pin, 2.0 mm,Exchange Pin 2.0mm,Exchange Pin, 3.2 mm,Exchange Pin 3.2mm,Fixed Parallel Pin Guide,Guide Pin, 2.0 mm,Guide Pin… |
|---|---|
| Owner/operator | SI-BONE, Inc. |
| Owner/operator number | 10029402 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | SI-BONE, INC. |
| Establishment registrations | 3007700286, 3021948057 |
| FEI numbers | 3007700286, 3021948057 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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