FDA device listing

7mm Offset Provisional Liner (export only),Elevated Provisional Liner (export only),Neutral Provisional Liner (export…

FDA device listing 1471049023 · LH Medical Corporation

Key facts

Proprietary names 7mm Offset Provisional Liner (export only),Elevated Provisional Liner (export only),Neutral Provisional Liner (export only),Oblique Provisional Liner (export only)
Owner/operator LH Medical Corporation
Owner/operator number 10042802
Product codes LPH
Device names LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class Class II
Classification regulations (21 CFR) 888.3358
Review panels Orthopedic
Registered establishments LH MEDICAL CORPORATION
Establishment registrations 3010057495
FEI numbers 3010057495
Establishment operations U.S. Manufacturer of Export Only Devices
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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