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Home » Sirakoss scores FDA nod for nanoparticle synthetic bone graft substitute
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Sirakoss scores FDA nod for nanoparticle synthetic bone graft substitute

June 18, 2020
By Nuala Moran
LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic calcium phosphate-based Osteo3 Zp putty consists of the granules suspended in a fully synthetic resorbable carrier.
Medical technology Newco news Regulatory Orthopedics 510(k) FDA

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