FDA device listing
RELINE
FDA device listing 1236923560 · GLOBUS MEDICAL, INC.
Key facts
| Proprietary names | RELINE |
|---|---|
| Owner/operator | GLOBUS MEDICAL, INC. |
| Owner/operator number | 9056090 |
| Premarket submissions | K160989 |
| Product codes | KWP, KWQ, MNH, MNI, NKB, OSH |
| Device names | 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 II |
| Classification regulations (21 CFR) | 888.3050, 888.3060, 888.3070 |
| Review panels | Orthopedic |
| Registered establishments | GLOBUS MEDICAL, INC., NML Medical, LLC |
| Establishment registrations | 3013491327, 3030412764 |
| FEI numbers | 3013491327, 3030412764 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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