FDA device listing

SYNTHES 5.0/7.3 MM CANNULATED LOCKI

FDA device listing 1766137810 · SYNTHES (USA) Products LLC / Medical Device Business Service

Key facts

Proprietary names SYNTHES 5.0/7.3 MM CANNULATED LOCKI
Owner/operator SYNTHES (USA) Products LLC / Medical Device Business Service
Owner/operator number 2520274
Premarket submissions K040765
Product codes JDW
Device names JDW - Pin, Fixation, Threaded
Device class Class II
Classification regulations (21 CFR) 888.3040
Review panels Orthopedic
Registered establishments DePuy Synthes Sales, Synthes (USA) Products LLC
Establishment registrations 3008812560, 3034676720
FEI numbers 3008812560, 3034676720
Establishment operations Repackager/Relabeler, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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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