Class Class II
Interwedge® Standalone Lateral (K241487)
Description
Interwedge® Standalone Lateral by Foundation Surgical Group, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241487
Clearance Date2024-10-02
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241487
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. Interwedge® Standalone Lateral (K241487) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Int... | Corelink, LLC | 2023 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ... | Nu Vasive, Incorporated | 2021 |
| K152277 | PIVOX(tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 |
Trace the full predicate network for K241487
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.