The U.S. Food and Drug Administration routinely inspects medical device facilities to assess quality and regulatory compliance. The FDA has an established framework of procedures for industry oversight in effort to protect the public and the integrity of the broader healthcare system. On December 21st 2018 Fusion Orthopedics, at their...
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Fusion Orthopedics Receives HammerTech Titanium 510K FDA Approval
Fusion Orthopedics Receives HammerTech Titanium 510K FDA Approval Fusion Orthopedics is pleased to announce HammerTech Titanium as the newest addition to their product offering. FDA 510(k) clearance was issued November 23rd, 2018. The assigned FDA 510(k) # for HammerTech is K182684. The new Class II titanium devices are a welcomed...
Fusion Orthopedics Acquires OrthoNoble
FOR IMMEDIATE RELEASE: Fusion Orthopedics is pleased to announce that it has acquired San Diego, California based OrthoNoble, LLC on November 9th, 2018. OrthoNoble is a sports-medicine medical device company specializing in the development of suture anchors for surgical treatment of ligament, tendon, and soft tissue pathologies. The assets center...