FDA device listing
Adapter,Control Gauges,Counter Torque,Dilatator,Distractor,Drill Guide,Forceps,Frames,Guiding instruments,Handle,Implant…
FDA device listing 1523175206 · Silony Medical GmbH
Key facts
| Proprietary names | Adapter,Control Gauges,Counter Torque,Dilatator,Distractor,Drill Guide,Forceps,Frames,Guiding instruments,Handle,Implant modifier,Inserter,Loading Block,Orthopedic manual surgical instrument,Paddle Sizer,Pusher,(Re-)Positioning Tools,Scraper,Shaver,Torque Limiter,Working Tower |
|---|---|
| Owner/operator | Silony Medical GmbH |
| Owner/operator number | 10054311 |
| 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 | SILONY MEDICAL GMBH, Silony Medical International AG, Silony Spine Corporation |
| Establishment registrations | 3012764194, 3013422236, 3013422238 |
| FEI numbers | 3012764194, 3013422236, 3013422238 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Foreign Exporter |
| 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