The U.S. Food and Drug Administration (FDA) has granted two 510 (k) clearances for implants which restore the integrity of ...
icotec, a leading company for the treatment of spinal tumours and spinal infections, announced that it has received FDA clearance for the use of BlackArmor implants in the treatment of de novo spinal ...
The US Food and Drug Administration (FDA) has granted clearance to icotec for the use of its BlackArmor implants in treating de novo spinal infections. This is claimed to make icotec the first and ...
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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).
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.
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.
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