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:

China
National Medical Product Administration
NMPA Registration

European Union
European Commission
CE Mark (EU MDR)

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

Japan
Pharmaceuticals and Medical Devices Agency (PMDA)
MHLW

Korea
KGMP (Korea Good Manufacturing Practice) Certification

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Hip implants including femoral heads and/or acetabular liners manufactured from Permallon® Avant 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)

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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 (EU MDR)

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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 and Permallon are registered trademarks of CoorsTek, Inc.