FDA device listing

Splint

FDA device listing 1735017528 · MicroPort Orthopedics Inc.

Key facts

Proprietary names Splint
Owner/operator MicroPort Orthopedics Inc.
Owner/operator number 10045253
Product codes ILH
Device names ILH - Splint, Hand, And Components
Device class Class I
Classification regulations (21 CFR) 890.3475
Review panels Physical Medicine
Registered establishments MICROPORT ORTHOPEDICS INC.
Establishment registrations 3010536692
FEI numbers 3010536692
Establishment operations Repackager/Relabeler, Specification Developer
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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