KHEIRON® Spinal Fixation System, including patient specific K-ROD (K251804)
Description
KHEIRON® Spinal Fixation System, including patient specific K-ROD by S.M.A.I.O, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251804
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. KHEIRON® Spinal Fixation System, including patient specific K-ROD (K251804) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232650 | KHEIRON® Spinal Fixation System, including patient specific... | S.M.A.I.O | 2023 |
| K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | 2022 |
| K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | 2022 |
Trace the full predicate network for K251804
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.