(Seoul=NSP NEWS) = CGBio has secured approval from the U.S. Food and Drug Administration(FDA) for its patient-customized titanium implants. With this approval, the company is set to target the U.S. market for skull and craniofacial reconstruction.
CGBio announced on the 22nd that its patient-customized titanium implant, 'EASYMADE TI', received FDA 510(k) approval on the 9th.
The FDA 510(k) is a representative pre-market approval procedure for medical devices sold in the United States. The company stated that this is the first time a domestic company has received FDA approval for a customized titanium implant for the U.S. market.
EASYMADE TI is a custom implant designed based on patient CT data. It is used for the reconstruction of the skull and non-weight-bearing craniofacial defects(parts of the facial bones that do not support body weight).
A CGBio official said, “The U.S. cranial implant market is expected to exceed $500 million in 2024,” adding, “An average annual growth rate of over 6% is projected from 2025 to 2034."
CGBio announced on the 22nd that its patient-customized titanium implant, 'EASYMADE TI', received FDA 510(k) approval on the 9th.
The FDA 510(k) is a representative pre-market approval procedure for medical devices sold in the United States. The company stated that this is the first time a domestic company has received FDA approval for a customized titanium implant for the U.S. market.
EASYMADE TI is a custom implant designed based on patient CT data. It is used for the reconstruction of the skull and non-weight-bearing craniofacial defects(parts of the facial bones that do not support body weight).
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