Class Class II
NEO Pedicle Screw System™ (K243693)
Description
NEO Pedicle Screw System™ by Neo Medical SA, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243693
Clearance Date2024-12-23
Clearance TypeSpecial
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243693
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. NEO Pedicle Screw System™ (K243693) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2022 |
Trace the full predicate network for K243693
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.