Class Class II
ANAX™ OCT Spinal System (K251725)
Description
ANAX™ OCT Spinal System by Cg Medtech Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251725
Clearance Date2025-06-25
Clearance TypeSpecial
Product CodeNKG
Regulation Number888.3075
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251725
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. ANAX™ OCT Spinal System (K251725) cites 9 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231737 | ANAX 5.5 Spinal System | Innosys Co., Ltd. | 2023 |
| K183383 | ANAX OCT Spinal System | U&I Corporation | 2018 |
| K173524 | ANAX 5.5 Spinal System | U&I Corporation | 2017 |
| K162189 | ANAX 5.5 Spinal System | U&I Corporation | 2016 |
| K150570 | ANAX OCT Spinal System | U&I Corporation | 2015 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015 |
| K132101 | ANAX 5.5 SPINAL SYSTEM | U&I Corporation | 2013 |
| K123656 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION ... | Medtronic Sofamor Danek USA, Inc. | 2013 |
| K110522 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION ... | Medtronic Sofamor Danek USA, Inc. | 2011 |
Trace the full predicate network for K251725
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.