FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K191906
·
Decision May 18, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
24
Review Days
307
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Basic Information
- 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
- K Number
- K191906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MiRus, LLC
- Date Received
- July 16, 2019
- Decision Date
- May 18, 2020
- Product Code
- MAX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by MiRus, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | Mar 18, 2026 | Substantially Equivalent |
| K252733 | ATLAS Expandable Osteotomy Wedge System | Feb 19, 2026 | Substantially Equivalent |
| K242516 | EUROPA Posterior Cervical Fusion System | Nov 19, 2024 | Substantially Equivalent |
| K241175 | MiRus MoRe Lumbar Plating System | May 17, 2024 | Substantially Equivalent |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | Oct 27, 2023 | Substantially Equivalent |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | Oct 13, 2023 | Substantially Equivalent |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | Sep 11, 2023 | Substantially Equivalent |
| K230369 | EUROPA Navigated Instruments | Jun 23, 2023 | Substantially Equivalent |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | Sep 16, 2022 | Substantially Equivalent |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | May 13, 2022 | Substantially Equivalent |