FDA device listing
ORTHOLOC 3Di Foot Reconstruction System,ORTHOLOC 3Di Hallux System
FDA device listing 1943417516 · STRYKER CORP.
Key facts
| Proprietary names | ORTHOLOC 3Di Foot Reconstruction System,ORTHOLOC 3Di Hallux System |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K120359 |
| Product codes | HRS |
| Device names | HRS - Plate, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | Stryker Macroom, Stryker Poland Manufacturing Sp. z o.o., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 3008337808, 3010667733, 3031800723 |
| FEI numbers | 1043534, 3008337808, 3010667733, 3031800723 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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