Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant [Yahoo! Finance]
KELYNIAM GLOBAL INC (KLYG)
Company Research
Source: Yahoo! Finance
implant solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fusion ™ Cranial and Craniofacial Implants. These implants are crafted from a unique combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), marking a groundbreaking advancement in implant technology. This 510(k) clearance marks the first time the FDA has approved this material for use in cranial and craniofacial implants, representing a significant milestone in implant technology. The Fusion ™ BCP-PEEK implant is the first totally new implant launched in the cranial and craniofacial market in 8 years. "Kelyniam's achievement as the first company in the U.S. to gain FDA clearance for Fusion ™ BCP-PEEK implants highlights our innovative spirit and dedication to advancing medical device technology," said Desiree Webb, Chief Operating and Revenue Officer. "Kelyniam's Fusion ™ BCP-PEEK implants are designed to encourag
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