Class Class II
IB3D™ PL Spinal System (K241164)
Description
IB3D™ PL Spinal System by Medicrea International S.A.S. (Medtronic), an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241164
Clearance Date2024-09-06
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241164
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. IB3D™ PL Spinal System (K241164) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Techno... | Medtronic Sofamor Danek | 2020 |
| K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC C... | Medtronic Sofamor Danek USA, Inc. | 2020 |
| K163595 | IMPIX 3D Print Cages | Medicrea International SA | 2017 |
Trace the full predicate network for K241164
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.