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NLT Spine receives FDA 510(k) clearance for spinal fusion procedures

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NLT Spine announced it received FDA 510(k) clearance for two of its generation 2.0 products designed for spinal fusion procedures, Prow Fusion and eSPIN.

Intended for spinal transforaminal lumbar interbody fusion procedures, Prow Fusion Interbody Fusion device and delivery system was developed based on NLT Spine’s non-linear core technology which allows for inserting large implants and instruments through a small incision. While the previous version of the device was already cleared by the FDA, generation 2.0 offers an enhanced design, new material and fewer instruments required to perform the procedure, according to a press release.

eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures. Generation 2.0 enhancements include an additional irrigation capability and optimized cutting tips design.

“The FDA clearance for two of our products strengthens our drive and commitment to continue and innovate to offer surgeons and patients a differentiated experience in less invasive spine procedures,” Didier Toubia, chief executive officer of NLT Spine, stated in a company press release. “Alongside a strong intellectual property and FDA clearance for these two leading products, our platform becomes a solid offering in this market. With additional products in our pipeline, we plan to quickly address most of the major segments of the spinal implants business, a $7.6 billion opportunity worldwide.”