Class Class II
Eminent Spine 3D Titanium Pedicle Screw System (K241663)
Description
Eminent Spine 3D Titanium Pedicle Screw System by Eminent Spine, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241663
Clearance Date2025-04-28
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241663
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. Eminent Spine 3D Titanium Pedicle Screw System (K241663) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K100377 | DIAMONDBACK SPINAL SYSTEM | Eminent Spine | 2010 |
| K041460 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2004 |
| K031655 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2003 |
| K022623 | 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) | Depuyacromed | 2002 |
Trace the full predicate network for K241663
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.