FDA device listing
PULSE
FDA device listing 1981819000 · GLOBUS MEDICAL, INC.
Key facts
| Proprietary names | PULSE |
|---|---|
| Owner/operator | GLOBUS MEDICAL, INC. |
| Owner/operator number | 9056090 |
| Premarket submissions | K180038 |
| Product codes | ETN, GWF, HAW, IKN, JAA, LLZ, OLO, OWB, PDQ |
| Device names | ETN - Stimulator, Nerve, GWF - Stimulator, Electrical, Evoked Response, HAW - Neurological Stereotaxic Instrument, IKN - Electromyograph, Diagnostic, JAA - System, X-Ray, Fluoroscopic, Image-Intensified, LLZ - System, Image Processing, Radiological, OLO - Orthopedic Stereotaxic Instrument, OWB - Interventional Fluoroscopic X-Ray System, PDQ - Neurosurgical Nerve Locator |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.1820, 882.1870, 882.4560, 890.1375, 892.1650, 892.2050 |
| Review panels | Ear, Nose, & Throat, Neurology, Physical Medicine, Radiology |
| Registered establishments | GLOBUS MEDICAL, INC. |
| Establishment registrations | 3030412764 |
| FEI numbers | 3030412764 |
| Establishment operations | Manufacturer |
| 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