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OSTEONICS APPROVAL FOR CONSTRAINED ACETABULAR INSERT CLEARS WAY FOR CONTINUED MARKETING; J&J S-ROM POLY-DIAL ACETABULAR LINE RECOMMENDED FOR APPROVAL

This article was originally published in The Gray Sheet

Executive Summary

Osteonics' constrained acetabular insert received FDA approval June 13, allowing the firm to continue marketing the preamendments Class III device. The approval came only three days after FDA's Orthopedic and Rehabilitation Devices Panel unanimously recommended on June 10 that the device was approvable with conditions.

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