FDA device listing
CD Horizon™ ModuLeX™ Spinal System
FDA device listing 1750580087 · Medtronic, Inc.
Key facts
| Proprietary names | CD Horizon™ ModuLeX™ Spinal System |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K221244 |
| Product codes | HBE, KWP, KWQ, NKB, OLO |
| Device names | HBE - Drills, Burrs, Trephines & Accessories (Simple, Powered), KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, NKB - Thoracolumbosacral Pedicle Screw System, OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4310, 882.4560, 888.3050, 888.3060, 888.3070 |
| Review panels | Neurology, 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 PUERTO RICO OPERATIONS CO., HUMACAO, MEDTRONIC SOFAMOR DANEK USA, INC., WARSAW ORTHOPEDIC, INC. |
| Establishment registrations | 1030489, 1824199, 2647346, 3003120897, 3005677016, 3009380063, 3014725904, 3018094310 |
| FEI numbers | 1824199, 2647346, 1000477302, 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
- 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