FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇭 Switzerland
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
K Number: K192281
·
Decision Nov 20, 2019
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
96
Review Days
90
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Basic Information
- Device Name
- AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
- K Number
- K192281
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos International SARL
- Date Received
- August 22, 2019
- Decision Date
- November 20, 2019
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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| K243249 | TriALTIS Spine System | Jan 17, 2025 | Substantially Equivalent |
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| K242042 | TriALTIS Spine System | Sep 9, 2024 | Substantially Equivalent |
| K233684 | TriALTIS Spine System | Dec 12, 2023 | Substantially Equivalent |
| K233366 | SYMPHONY OCT System | Nov 9, 2023 | Substantially Equivalent |
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| K231479 | TriALTIS Spine System | Sep 22, 2023 | Substantially Equivalent |