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Integra®

Ascension Orthopedics, Inc. · Model PYROLUNINSTP · UDI-DI 10381780235040

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Description

The Integra Lunate system is intended for replacement of the lunate bone in the proximal carpal row of the wrist. The set includes five trials to evaluate the size and fit of the implant. Five sizing templates are also included to assess coverage and establish proper sizing for the component.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.