FDA device listing

Traction Splint

FDA device listing 1875483174 · Zhangjiagang New Fellow Med Co., Ltd.

Key facts

Proprietary names Traction Splint
Owner/operator Zhangjiagang New Fellow Med Co., Ltd.
Owner/operator number 10096081
Product codes HSP
Device names HSP - Splint, Traction
Device class Class I
Classification regulations (21 CFR) 888.5890
Review panels Orthopedic
Registered establishments ZHANGJIAGANG NEW FELLOW MED CO., LTD.
Establishment registrations 3038141559
FEI numbers 3038141559
Establishment operations 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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