FDA device listing

Verte-Stack Perimeter XS

FDA device listing 1527399961 · Medtronic, Inc.

Key facts

Proprietary names Verte-Stack Perimeter XS
Owner/operator Medtronic, Inc.
Owner/operator number 2112641
Premarket submissions K062073
Product codes MQP
Device names MQP - Spinal Vertebral Body Replacement Device
Device class Class II
Classification regulations (21 CFR) 888.3060
Review panels Orthopedic
Registered establishments Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH, MEDTRONIC SOFAMOR DANEK USA, INC.
Establishment registrations 1030489, 3003120897, 3011795235, 3018094310
FEI numbers 1000477302, 3003120897, 3011795235, 3018094310
Establishment operations Complaint File Establishment, Manufacturer, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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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