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FDA approves intervertebral body fusion device

Issue: March 2013

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K7 LLC announced 510(k) approval from the FDA for its K7C Cervical Spacer for use as an intervertebral body fusion device with Evonik’s Vestakeep Peek.

According to a company press release, this is the first time a Vestakeep Peek-based spinal fusion medical device has gained 510(k) approval. Vestakeep Peek has sterilization resistance and a combination of stiffness and ductility, making it suitable for medical implant applications that must meet high mechanical, thermal and chemical requirements.

“The inherent strength and added ductility have created new possibilities for our Peek implant designs,” Michael Smith, founder and chief executive officer of K7 LLC, stated in the release.