FDA device listing
Threaded Cement Restrictor Ti
FDA device listing 1823310248 · Medtronic, Inc.
Key facts
| Proprietary names | Threaded Cement Restrictor Ti |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K011443 |
| Product codes | JDK |
| Device names | JDK - Prosthesis, Hip, Cement Restrictor |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.3300 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC SOFAMOR DANEK USA, INC., WARSAW ORTHOPEDIC, INC. |
| Establishment registrations | 1030489, 1824199, 3018094310 |
| FEI numbers | 1824199, 1000477302, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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