FDA device listing

Screw, Fixation, Bone

FDA device listing 1914346950 · Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Key facts

Owner/operator Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Owner/operator number 10047115
Product codes HWC
Device names HWC - Screw, Fixation, Bone
Device class Class II
Classification regulations (21 CFR) 888.3040
Review panels Orthopedic
Registered establishments SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.
Establishment registrations 3008749819
FEI numbers 3008749819
Establishment operations Contract 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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