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FDA 510(k), K191906, MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
FDA 510(k), K191906, MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
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510(K) Number: K191906
Device Name: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
Manufacturer: MiRus, LLC
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 07/16/2019
Decision Date: 05/18/2020
Regulation Medical Specialty: Orthopedic
Device Name: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
Manufacturer: MiRus, LLC
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 07/16/2019
Decision Date: 05/18/2020
Regulation Medical Specialty: Orthopedic
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