FDA device listing

NuVasive Triad Facet Screw System

FDA device listing 1964185019 · NUVASIVE, INC.

Key facts

Proprietary names NuVasive Triad Facet Screw System
Owner/operator NUVASIVE, INC.
Owner/operator number 9036345
Premarket submissions K020411
Product codes MRW
Device names MRW - System, Facet Screw Spinal Device
Device class Unclassified
Classification regulations (21 CFR) ORCA1.MRW
Review panels Orthopedic
Registered establishments NUVASIVE, INC.
Establishment registrations 2031966, 3009144915
FEI numbers 3002980729, 3009144915
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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