RegulatorySpine

FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients

July 24, 2018

AARHUS, Denmark–(BUSINESS WIRE)–FBC Device ApS, a medical device company focused on restoring natural alignment of the spine through innovative interbody implants, has received its first US FDA clearance for its technology, enabling access to the US market.

Professor Finn Christensen, MD, PhD and founder and CEO of FBC Device says: “There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results. We have now accomplished three elements crucial to reaching our goal:

  • Regulatory approval, now in the US along with a second implant that has been CE marked since 2013.
  • Patents granted around the world to protect these two implant designs as well as others to follow.
  • Documented clinical evidence demonstrating that the technology enables surgeons to restore normal alignment and that patients receiving the technology have excellent results in patient-based outcome measures.”

The FDA clearance brings FBC Device one step closer to its goal. To fully commercialize its products, the Company will immediately engage interested parties capable of bringing the technology to large markets across the world.

For more information, visit www.fbcdevice.com

About the FBC Technology

Each individual has different alignment requirements – it is not one size fits all. The FBC technology is a two-piece interbody fusion device that allows for in-situ adjustment from 9-21 degrees, enabling surgeons to simply adjust alignment for each patient’s need and then lock the two pieces relative to each other.

Contacts

FBC Device ApS
Prof. FB Christensen
Email – finn@fbcdevice.com

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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