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CoorsTek Bioceramics Regulatory Information

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Regulatory Information

Devices incorporating products sold by CoorsTek Bioceramics are registered by our customers.

 

Hip implants including femoral heads and/or acetabular liners manufactured from Permallon™ Tru Alumina Matrix Composite ceramic are registered by customers of CoorsTek Bioceramics in the following locations:

United States
U.S. Food and Drug Administration
510(k)

European Union
European Commission
CE Mark

Japan
Pharmaceuticals and Medical Devices Agency (PMDA)
MHLW

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Spinal cervical discs including components manufactured from Permallon™ Tru Alumina Matrix Composite ceramic are registered by customers of CoorsTek Bioceramics in the following locations:

United States
U.S. Food and Drug Administration
PMA

European Union
European Commission
CE Mark

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Brachytherapy seeds including CoorsTek components are registered by customers of CoorsTek Bioceramics in the following locations:

United States
U.S. Food and Drug Administration
510(k)

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Cochlear implants including components manufactured from CoorsTek ceramic are registered by customers of CoorsTek Bioceramics in the following locations:

United States
U.S. Food and Drug Administration
PMA

European Union
European Commission
CE Mark

 

Additional regulatory approvals pending. All other CoorsTek Bioceramics products referenced or discussed in our marketing literature not listed above are not currently registered or commercially available.

CoorsTek Bioceramics is a wholly owned subsidiary of CoorsTek, Inc. CoorsTek is a registered trademark of CoorsTek, Inc. Permallon is a trademark of CoorsTek, inc.

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