FDA device listing

Nexus Spine

FDA device listing 1944928497 · Nexus Spine, LLC.

Key facts

Proprietary names Nexus Spine
Owner/operator Nexus Spine, LLC.
Owner/operator number 10048422
Premarket submissions K223627
Product codes KWQ
Device names KWQ - Appliance, Fixation, Spinal Intervertebral Body
Device class Class II
Classification regulations (21 CFR) 888.3060
Review panels Orthopedic
Registered establishments NEXUS SPINE, L.L.C., NEXUS SPINE, LLC.
Establishment registrations 3011390763, 3018210489
FEI numbers 3011390763, 3018210489
Establishment operations Complaint File Establishment, 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

Browse all FDA device listings