FDA device listing

Cure™ Lumbar Plate System

FDA device listing 1879112920 · Machining Midtown LLC

Key facts

Proprietary names Cure™ Lumbar Plate System
Owner/operator Machining Midtown LLC
Owner/operator number 10061055
Product codes KWQ
Device names KWQ - Appliance, Fixation, Spinal Intervertebral Body
Device class Class II
Classification regulations (21 CFR) 888.3060
Review panels Orthopedic
Registered establishments Machining Midtown LLC
Establishment registrations 3015709929
FEI numbers 3015709929
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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