Kelyniam Global Receives FDA 510(k) Approval for Custom Craniofacial Implants
Published: Oct 15, 2012
The approval allows Kelyniam to expand its customer base and pursue ENT doctors, plastic surgeons, Facial/Cranial surgeons, military hospitals and government agencies. Patients with maxiofacial defects resulting from trauma or oncologic resection may now benefit from a superior-fitting PEEK implant made by Kelyniam. The company anticipates sales to begin in the 4th quarter of 2012.
"We seek to replicate the success and market penetration experienced in the custom cranial market" said President Tennyson Anthony. "The company has sold custom cranial implants in about 25 states this year and can quickly plug this new product offering into medical centers in those states."
Kelyniam Global will participate in the Congress of Neurological Surgeons Annual Meeting October 8th-10th in Chicago.
The company anticipates releasing Q2 financials in the coming weeks.
About Kelyniam Global, Incorporated
Kelyniam Global Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
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