Atlas FDA

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) clearance K191906 · decided 2020-05-18

Clearance details

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
Applicant
MiRus, LLC
Decision
Substantially Equivalent
Date received
2019-07-16
Decision date
2020-05-18
Days to decision
307 days
Clearance type
Traditional
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Marietta, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.