FDA device listing

TITANIUM HIP - CATALOG 1019 XX XXXSTEMS &1365 XX XXX HEADS

FDA device listing 1091659905 · Exel Inc. dba DHL Supply Chain (USA)

Key facts

Proprietary names TITANIUM HIP - CATALOG 1019 XX XXXSTEMS &1365 XX XXX HEADS
Owner/operator Exel Inc. dba DHL Supply Chain (USA)
Owner/operator number 10026656
Premarket submissions K843909
Product codes JDI
Device names JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class Class II
Classification regulations (21 CFR) 888.3350
Review panels Orthopedic
Registered establishments EXEL INC. DBA DHL SUPPLY CHAIN (USA)
Establishment registrations 3008868758
FEI numbers 3008868758
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

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