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Biomet Submits New 510(k) For Signature, Reports Disappointing Q1

This article was originally published in The Gray Sheet

Executive Summary

Biomet has submitted a new 510(k) for its Signature personalized knee surgery instrumentation system to help resolve a July 27 FDA warning letter, according to CEO Jeffrey Binder.

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FDA Warning Letters Target Personalized Knee Surgery Systems

FDA's device center is warning two different orthopedic firms that the companies' personalized knee surgery instrumentation systems are being marketed without proper clearance or approval


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