FDA device listing

NUBIC SPINAL IMPLANT SYSTEM,NUBIC XL SPINAL IMPLANT SYSTEM,RABEA SPINAL IMPLANT SYSTEM,TOSCA connector screw (ATM309T)

FDA device listing 1167933524 · ProCon Medizintechnik GmbH

Key facts

Proprietary names NUBIC SPINAL IMPLANT SYSTEM,NUBIC XL SPINAL IMPLANT SYSTEM,RABEA SPINAL IMPLANT SYSTEM,TOSCA connector screw (ATM309T)
Owner/operator ProCon Medizintechnik GmbH
Owner/operator number 10044518
Product codes MQP, ODP
Device names MQP - Spinal Vertebral Body Replacement Device, ODP - Intervertebral Fusion Device With Bone Graft, Cervical
Device class Class II
Classification regulations (21 CFR) 888.3060, 888.3080
Review panels Orthopedic
Registered establishments PROCON MEDIZINTECHNIK GMBH
Establishment registrations 3005076207
FEI numbers 3005076207
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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