MEDICREA receives FDA approval for K-JAWS Cervical Compression Staple

MEDICREA received approval from the U.S. Food and Drug Administration for the K-JAWS Cervical Compression Staple for all cervical fixation indications carried out with interbody cages.

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The implant is less invasive and quick to insert. It involves fixing two adjacent vertebra by compression around a previously-inserted interbody cage.

 

“Following an examination of the product’s clinical data — almost 5,000 units have already been implanted outside the United States since the product’s launch in 2006 — the FDA has approved our cervical staple in the US market for the same indications as cervical plates. This approval has given rise to the creation of a new product code in the FDA’s internal classification, giving the product a unique position on the spinal column fixation device market,” said Denys Sournac, chairman and CEO of MEDICREA.

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