RegulatorySpine

FDA Grants Clearance on Nexxt Spine ALIF and Lateral Systems

Additional FDA clearances roll in for growing spinal manufacturer to be available Q3

May 28, 2020- Noblesville, IN– Nexxt Spine LLC, a leading manufacturer of spinal surgery solutions is proud to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of two lumbar based systems; ALIF and Lateral.   This milestone will allow the company to commence in-house manufacturing of the two systems and plan for subsequent alpha launches in August and September respectively.

Both systems will showcase the innovative Nexxt Matrixx® 3D printed titanium technology unique to the company.  Recognized for sound science behind each interbody, Nexxt Spine has created the desired pore size and geometry that is now available in ALIF and Lateral.  Coupled with a modulus of elasticity lower than PEEK, microroughened surface technology and a 75% porous lattice there is no question Nexxt Spine is commanding industry attention.

“We are thrilled to be releasing these two powerhouses this year,” states President Andy Elsbury.  “Our engineering and 3D printing manufacturing teams has been working diligently to simultaneously develop and clear the two products after considerable surgeon demand for Nexxt Spine quality clinical outcomes for ALIF and Lateral approaches.”

Forecasted Summer launch dates are as follows: ALIF in August 2020 and Lateral in September 2020.  An integrated plate system is expected to be launched for each product in Q4.

Products are available to current distributor partners. Ask how you can grow with us. Email sales@nexxtspine.com.

Contact Lindsey Bockhorst for media inquiries: lbockhorst@nexxtspine.com.

About Nexxt Spine:

Founded in 2009, Nexxt Spine LLC is a privately held manufacturer of spinal implants and instrumentation headquartered in Noblesville, IN. Nexxt Spine manufactures their own product line therefore offering exceptional quality, American-made implants, hardware, and custom instrumentation for a range of spinal implant needs. For more information, visit www.nexxtspine.com.

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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