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Medical Devices / Submissions and Approvals

FDA Grants Premarket Approval for Kelyniam’s Custom Cranial Implants

June 6, 2019
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The FDA handed Kelyniam Global premarket approval for its PEEK cranio-maxillofacial implant family.

The approval allows the devicemaker to sell its PEEK cranial implant with an integrated fixation system for a better fit. The fixation tabs can render cranioplasty plates unnecessary and make procedures less expensive.

Using the implant, surgeons are able to choose where to place the fixation tabs in order to ensure the implant fits precisely.

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