FDA device listing
Paragon 28
FDA device listing 1956612408 · Summit Orthopedic Technologies Inc.
Key facts
| Proprietary names | Paragon 28 |
|---|---|
| Owner/operator | Summit Orthopedic Technologies Inc. |
| Owner/operator number | 10051828 |
| Product codes | HWD |
| Device names | HWD - Starter, Bone Screw |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Summit Orthopedic Technologies Inc. |
| Establishment registrations | 3012491394 |
| FEI numbers | 3012491394 |
| Establishment operations | Contract 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