Policy & Regulation
NLT SPINE gets FDA approval for PROW FUSION device
2 February 2012 - Israel-based medical technology firm NLT SPINE said on Thursday it had received 510(k) clearance from the US Food and Drug Administration (FDA) for its lumbar interbody fusion device PROW FUSION.

The PROW FUSION Transforaminal-Lumbar Interbody Fusion (TLIF) device and delivery system are intended for spinal fusion in TLIF procedures. The product was developed using the company's non-linear core technology invented by Tzony Siegal which allows for inserting large implants and instruments through a small incision with minimal disruption to muscles and surrounding tissues.

The PROW FUSION device has a footprint that is larger than other TLIF devices to provide greater biomechanical stability. The product also allows for greater bone graft-to-endplate contact surface area, potentially improving fusion rates. The device is expected to benefit both patients and surgeons offering the former faster recovery and providing the latter with efficient and user-friendly minimally-invasive spinal surgery procedures, the company said.
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