Class Class II
Vertiwedge® Intraosseous System (K241468)
Description
Vertiwedge® Intraosseous System by Foundation Surgical Group, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241468
Clearance Date2024-11-07
Clearance TypeTraditional
Product CodeMQP
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241468
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. Vertiwedge® Intraosseous System (K241468) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024 |
| K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019 |
| K171140 | Matrixx System | Nexxt Spine, LLC | 2017 |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | Blackstone Medical, Inc. | 2008 |
Trace the full predicate network for K241468
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.