FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
SYMPHONY Navigation Ready Instruments
K Number: K260240
·
Decision Mar 27, 2026
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
96
Review Days
60
Basic Information
- Device Name
- SYMPHONY Navigation Ready Instruments
- K Number
- K260240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos International SARL
- Date Received
- January 26, 2026
- Decision Date
- March 27, 2026
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
Dynamis Robotic Surgical System
FDA 510(k)
FDA Class 2
·Neurology
CORUS Navigation System-GN
FDA 510(k)
FDA Class 2
·Neurology
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Navigated LLIF Impactable Tracker
FDA 510(k)
FDA Class 2
·Neurology
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
FDA 510(k)
FDA Class 2
·Neurology
Ion-C Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K253249 | TriALTIS Spine System | Oct 21, 2025 | 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 |