FDA device listing

Screw, Fixation, Bone

FDA device listing 1063408777 · Microware Precision Co., Ltd.

Key facts

Owner/operator Microware Precision Co., Ltd.
Owner/operator number 10028733
Product codes HWC, KTT
Device names HWC - Screw, Fixation, Bone, KTT - Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class Class II
Classification regulations (21 CFR) 888.3030, 888.3040
Review panels Orthopedic
Registered establishments MICROWARE PRECISION CO., LTD.
Establishment registrations 3007738812
FEI numbers 3007738812
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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