FDA device listing

Cannulated T7 Driver Shaft, QC,Fitting AutoFIX 2.0/2.5,Variable Angle 3mm Hex Driver,Variable Angle 4mm Hex Driver

FDA device listing 1507034088 · IN'TECH MEDICAL SAS

Key facts

Proprietary names Cannulated T7 Driver Shaft, QC,Fitting AutoFIX 2.0/2.5,Variable Angle 3mm Hex Driver,Variable Angle 4mm Hex Driver
Owner/operator IN'TECH MEDICAL SAS
Owner/operator number 9044399
Product codes HXX
Device names HXX - Screwdriver
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments IN'TECH MEDICAL SAS
Establishment registrations 9611579
FEI numbers 3002904345
Establishment operations Contract Manufacturer, Foreign Exporter
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

Browse all FDA device listings