Bioretec submitted the De Novo market authorization request for the RemeOs™ trauma screw to the FDA in
"Our work on this approval process is nearing completion, and we await the FDA's decision-making process and obtaining market authorization for the RemeOs™ trauma screw during April," says Timo Lehtonen, CEO of Bioretec.
Further inquiries
Timo Lehtonen, CEO, m. +358 50 433 8493
Johanna Salko, CFO, m. +358 40 754 8172
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Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their
Better healing - Better life. www.bioretec.com
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