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.
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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