FDA device listing

Varian Cage

FDA device listing 1219792394 · Medyssey Co., Ltd.

Key facts

Proprietary names Varian Cage
Owner/operator Medyssey Co., Ltd.
Owner/operator number 10028329
Premarket submissions K172756
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 MEDYSSEY CO., LTD.
Establishment registrations 3007485169
FEI numbers 3007485169
Establishment operations Manufacturer
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