Class Class II
sagAlign Lumbar Cage System (Various PNs) (K241413)
Description
sagAlign Lumbar Cage System (Various PNs) by Acuity Surgical Devices, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241413
Clearance Date2024-07-17
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241413
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. sagAlign Lumbar Cage System (Various PNs) (K241413) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222561 | Align | Acuity Surgical Devices, LLC | 2022 |
| K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | 2022 |
| K080537 | L-VARLOCK | Kiscomedica S.A. | 2008 |
Trace the full predicate network for K241413
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.