Lincotek Medical receives FDA clearance for SpineLinc AM implant
The medical division of Lincotek Group, headquartered in Rubbiano, Italy, has announced that the US Food and Drug Administration (FDA) has granted 510k clearance for the company’s SpineLinc Anterior Cervical Implant System. This system was manufactured, assembled and packaged at Lincotek’s Memphis, Tennessee, facility.
The SpineLinc body is available in multiple footprints, device heights and lordosis angles. It makes use of the additively manufactured Lincotek Bonepore 3D Titanium Porous Structure Technology, characterised by the company’s FDA master file. The product also contains machined plate and screw components and is offered with single-use instruments designed to be compatible with the needs of Ambulatory Surgical Centers (ASCs).
“This new approval is great news for OEMs, as it reduces time to market,” stated Troy Walters, the Product Development Director of Lincotek’s Medical Division. “SpineLinc demonstrates our understanding of customers’ need for market-ready solutions and the critical importance of acting quickly. By aligning our expertise with their priorities, we can transform ideas into commercial success faster and more efficiently.”
Francesco Bucciotti, Head of Global and Business Development at Lincotek’s Medical Division, added, “The 510k approval by the FDA is an important landmark, because SpineLinc has such a great potential having been engineered with OEMs, surgeons and patients in mind.”
The new product is available to OEMs for private labelling and can also be used as a predicate device by orthopaedic manufacturers to improve the speed of product development for similar devices.
