FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
TriALTIS Spine System
K Number: K253249
·
Decision Oct 21, 2025
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
96
Review Days
22
Basic Information
- Device Name
- TriALTIS Spine System
- K Number
- K253249
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos International SARL
- Date Received
- September 29, 2025
- Decision Date
- October 21, 2025
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Medos International SARL
| K Number | Device Name | ||
|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | May 26, 2026 | Substantially Equivalent |
| K260240 | SYMPHONY Navigation Ready Instruments | Mar 27, 2026 | Substantially Equivalent |
| K243249 | TriALTIS Spine System | Jan 17, 2025 | Substantially Equivalent |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Sep 16, 2024 | Substantially Equivalent |
| 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 |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Oct 6, 2023 | Substantially Equivalent |
| K231479 | TriALTIS Spine System | Sep 22, 2023 | Substantially Equivalent |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Feb 10, 2023 | Substantially Equivalent |