FDA device listing

THIEBAUD

FDA device listing 1179613461 · THIEBAUD SAS

Key facts

Proprietary names THIEBAUD
Owner/operator THIEBAUD SAS
Owner/operator number 10023100
Product codes OAR
Device names OAR - Injector, Vertebroplasty (Does Not Contain Cement)
Device class Class I
Classification regulations (21 CFR) 888.4200
Review panels Orthopedic
Registered establishments THIEBAUD SAS
Establishment registrations 3006798004
FEI numbers 3006798004
Establishment operations Complaint File Establishment, Contract Sterilizer, 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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