NEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use [Yahoo! Finance]
KELYNIAM GLOBAL INC (KLYG)
Company Research
Source: Yahoo! Finance
today that the NEOS Surgery Cranial LOOP™ fixation system has received 510(k) clearance from the FDA for use with Finceramica's CustomizedBone™ hydroxyapatite cranial implant. The Cranial LOOP™ family of cranial fixation devices is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps after craniotomies. With more than 10 years of market experience, Cranial LOOP™ is being used in public and private hospitals in 25 countries worldwide. Cranial LOOP™ was first cleared by the FDA in 2010. The most recent 510k clearance is for use specifically with Finceramica's CustomizedBone™ hydroxyapatite cranial implant. Ross Bjella , Kelyniam's CEO, said, "This approval will further boost Kelyniam's sales momentum which started in Q4 last year. Alongside the low infection rate and pediatric indication, the rapid fixation provided by the Cranial LOOP™ system is now an added benefit for neurosurgeons choosing CustomizedBone™ for their patients." Since 2004
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