FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K Number: K253721
·
Decision Dec 17, 2025
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
10
Review Days
23
Basic Information
- Device Name
- KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K Number
- K253721
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.M.A.I.O
- Date Received
- November 24, 2025
- Decision Date
- December 17, 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 S.M.A.I.O
| K Number | Device Name | ||
|---|---|---|---|
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | Apr 3, 2026 | Substantially Equivalent |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | Jan 7, 2026 | Substantially Equivalent |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | Jul 8, 2025 | Substantially Equivalent |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | Sep 29, 2023 | Substantially Equivalent |
| K223841 | KBA3D | May 30, 2023 | Substantially Equivalent |
| K211981 | KHEIRON® Spinal Fixation System | Jun 9, 2022 | Substantially Equivalent |
| K213975 | KEOPS Balance Analyzer 3D | May 6, 2022 | Substantially Equivalent |
| K211414 | KHEIRON Spinal Fixation System | Aug 10, 2021 | Substantially Equivalent |
| K201659 | KHEIRON® Spinal Fixation System | Oct 5, 2020 | Substantially Equivalent |