FDA device listing

NEXXT MATRIXX

FDA device listing 1696897602 · Nexxt Spine LLC

Key facts

Proprietary names NEXXT MATRIXX
Owner/operator Nexxt Spine LLC
Owner/operator number 10030542
Premarket submissions K200969
Product codes MAX
Device names MAX - Intervertebral Fusion Device With Bone Graft, Lumbar
Device class Class II
Classification regulations (21 CFR) 888.3080
Review panels Orthopedic
Registered establishments NEXXT SPINE LLC
Establishment registrations 3007922509
FEI numbers 3007922509
Establishment operations Complaint File Establishment, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1,000+ 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

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