KHEIRON® Spinal Fixation System, including patient specific K-ROD— 510(k) K253721
Substantially EquivalentS.M.A.I.O
FDA 510(k) clearance K253721 for KHEIRON® Spinal Fixation System, including patient specific K-ROD, Substantially Equivalent on 2025-12-17. Applicant: S.M.A.I.O. Device class: 2.
Clearance details
- Applicant
- S.M.A.I.O
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saint-Priest, FR
Recent devices under product code NKB
view all- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from S.M.A.I.O
view all- K261500 — KBA3D (v2.4.0)
- K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.