FDA device listing

Wheelhouse Medical Specials

FDA device listing 1874999402 · WHEELHOUSE MEDICAL

Key facts

Proprietary names Wheelhouse Medical Specials
Owner/operator WHEELHOUSE MEDICAL
Owner/operator number 10084227
Product codes LXH
Device names LXH - Orthopedic Manual Surgical Instrument
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments WHEELHOUSE MEDICAL
Establishment registrations 3021559833
FEI numbers 3021559833
Establishment operations Complaint File Establishment, 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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