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
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.
You may also be interested in...
FDA's Orthopedic Devices Panel is expected to review at its next meeting a petition from the Orthopedic Surgical Manufacturers Association requesting that the agency reclassify constrained metal/polymer hip joint prostheses, according to the association.
Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker