FDA device listing
CD HORIZON® Fenestrated Screw Set,KYPHON Cement Delivery System,KyphX Bone Filler Device
FDA device listing 1160966133 · Medtronic, Inc.
Key facts
| Proprietary names | CD HORIZON® Fenestrated Screw Set,KYPHON Cement Delivery System,KyphX Bone Filler Device |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Product codes | KIH |
| Device names | KIH - Dispenser, Cement |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4200 |
| Review panels | Orthopedic |
| Registered establishments | Medtronic (Changzhou) Medical Devices Technology Co., Ltd, Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC), Medtronic Medical Costa Rica S.R.L., Medtronic Mexico S. de R.L. de CV, MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO, MEDTRONIC SOFAMOR DANEK USA, INC., WARSAW ORTHOPEDIC, INC. |
| Establishment registrations | 1030489, 1824199, 2647346, 9617601, 3003120897, 3005677016, 3009380063, 3014725904, 3018094310 |
| FEI numbers | 1824199, 2647346, 1000477302, 3002534070, 3003120897, 3005677016, 3009380063, 3014725904, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, 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