FDA device listing
Blustone Synergy Basalt/Obsidian/Magma Lumbar Trial/Spreader,Blustone Synergy Slate Lordotic Cervical Trial,Blustone…
FDA device listing 1427096556 · Blustone Synergy, LLC
Key facts
| Proprietary names | Blustone Synergy Basalt/Obsidian/Magma Lumbar Trial/Spreader,Blustone Synergy Slate Lordotic Cervical Trial,Blustone Synergy Slate Parallel Cervical Trial |
|---|---|
| Owner/operator | Blustone Synergy, LLC |
| Owner/operator number | 10055810 |
| Product codes | HWT |
| Device names | HWT - Template |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4800 |
| Review panels | Orthopedic |
| Registered establishments | BLUSTONE SYNERGY, LLC |
| Establishment registrations | 3014019090 |
| FEI numbers | 3014019090 |
| Establishment operations | Specification Developer |
| 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