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FDA grants clearance to icotec’s BlackArmor implants to treat spinal infectionThe Centers for Medicare and Medicaid Services (CMS) has approved the implants for New Technology Add-on Payment (NTAP).
FDA clearance for the use of BlackArmor implants in the treatment of de novo spinal infections. icotec is honoured to be the first and only company in the United States with FDA 510(k) clearance for ...
In addition to the on-label designation, the FDA has also granted a Breakthrough Device Designation (BDD) for this indication across the entirety of icotec's BlackArmor® spinal stabilization ...
EAST HARTFORD, Conn., Jan. 14, 2025 /PRNewswire/ -- icotec is proud to announce that it has received FDA clearance for the use of BlackArmor® implants in the treatment of de novo spinal infections.
EAST HARTFORD, Conn., Jan. 14, 2025 /PRNewswire/ -- icotec is proud to announce that it has received FDA clearance for the use of BlackArmor® implants in the treatment of de novo spinal infections.
Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.
From device clearances to mergers, here are five developments from spine and orthopedic devicemakers since Jan. 8.
The U.S. Food and Drug Administration (FDA) has granted two 510 (k) clearances for implants which restore the integrity of ...
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