Class Class II
CarboClear® Hybrid Pedicle Screw System (K243106)
Description
CarboClear® Hybrid Pedicle Screw System by CarboFix Orthopedics , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243106
Clearance Date2024-11-05
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243106
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. CarboClear® Hybrid Pedicle Screw System (K243106) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2024 |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid... | CarboFix Orthopedics , Ltd. | 2024 |
| K130291 | S4 SPINAL SYSTEM | Aesculap Implant System, Inc. | 2013 |
| K082236 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2008 |
Trace the full predicate network for K243106
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.