FDA device listing
CD HORIZON Spinal System
FDA device listing 1580048551 · Medtronic, Inc.
Key facts
| Proprietary names | CD HORIZON Spinal System |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K153463 |
| Product codes | HWE, KWP, KWQ, MNH, MNI, NKB, OSH |
| Device names | HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, KWP - Appliance, Fixation, Spinal Interlaminal, KWQ - Appliance, Fixation, Spinal Intervertebral Body, MNH - Orthosis, Spondylolisthesis Spinal Fixation, MNI - Orthosis, Spinal Pedicle Fixation, NKB - Thoracolumbosacral Pedicle Screw System, OSH - Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 878.4820, 888.3050, 888.3060, 888.3070 |
| Review panels | General & Plastic Surgery, Orthopedic |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC SOFAMOR DANEK USA, INC. |
| Establishment registrations | 1030489, 3003120897, 3018094310 |
| FEI numbers | 1000477302, 3003120897, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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