FDA device listing

Double Medical Cage System

FDA device listing 1323525221 · Double Medical Technology Inc.

Key facts

Proprietary names Double Medical Cage System
Owner/operator Double Medical Technology Inc.
Owner/operator number 10045395
Premarket submissions K172828
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 Double Medical Technology Inc.
Establishment registrations 3010440433
FEI numbers 3010440433
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

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