FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Ion-L
K Number: K261209
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
25
Review Days
59
Basic Information
- Device Name
- Ion-L
- K Number
- K261209
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SurGenTec, LLC
- Date Received
- April 13, 2026
- Decision Date
- June 11, 2026
- 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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|---|---|---|---|
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| K251714 | Ion-C | Jan 16, 2026 | Substantially Equivalent |
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| K243580 | GraftGun Universal Graft Delivery System (GDS) | Feb 5, 2025 | Substantially Equivalent |
| K243835 | TiLink-P SI Joint Fusion System | Dec 27, 2024 | Substantially Equivalent |
| K242797 | OsteoFlo HydroFiber | Dec 23, 2024 | Substantially Equivalent |
| K243265 | Ion 3D | Dec 4, 2024 | Substantially Equivalent |