FDA device listing

Swift-Lock Anchor

FDA device listing 1662465378 · ABBOTT LABORATORIES

Key facts

Proprietary names Swift-Lock Anchor
Owner/operator ABBOTT LABORATORIES
Owner/operator number 1415939
Premarket submissions K092371
Product codes GZB
Device names GZB - Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class Class II
Classification regulations (21 CFR) 882.5880
Review panels Neurology
Registered establishments Abbott Medical
Establishment registrations 1627487
FEI numbers 1627487
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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