FDA device listing
Gravity Peek Suture Anchor,Hoffmann 3 Military External Fixator Kit,Reduction Instruments Complete Kit
FDA device listing 1657096493 · STRYKER CORP.
Key facts
| Proprietary names | Gravity Peek Suture Anchor,Hoffmann 3 Military External Fixator Kit,Reduction Instruments Complete Kit |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | OJH |
| Device names | OJH - Orthopedic Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | STRYKER GmbH, WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 8031020, 3010667733 |
| FEI numbers | 1043534, 3002807830, 3010667733 |
| Establishment operations | Manufacturer, 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