Class Class II
X-PAC® N-GAGE™ Lumbar Plate System (K250602)
Description
X-PAC® N-GAGE™ Lumbar Plate System by Expanding Innovations, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250602
Clearance Date2025-05-20
Clearance TypeTraditional
Product CodeKWQ
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250602
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. X-PAC® N-GAGE™ Lumbar Plate System (K250602) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | 2023 |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation | 2020 |
Trace the full predicate network for K250602
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.