Anax™ OCT Spinal System
Anax OCT Spinal System stabilizes the craniocervical junction, cervical spine and upper thoracic spine as an adjunct to fusion. It combines polyaxial screws, hooks, rods, set screws,…
Anax OCT Spinal System stabilizes the craniocervical junction, cervical spine and upper thoracic spine as an adjunct to fusion. It combines polyaxial screws, hooks, rods, set screws, crosslinks, connectors and an occipital plate.
Single-use components are supplied nonsterile and use titanium alloy or cobalt-chromium-molybdenum alloy. Polyaxial screws are self-tapping, and specialized stainless steel instruments support application and removal.
Indications and Extensions
Indications include trauma, instability, deformity, failed fusion, cervical tumors and specified degenerative disease. Limited stabilization without fusion is also intended for advanced cervical tumors when life expectancy is insufficient for fusion. Connectors and transition rods can link to Perfix and Anax 5.5 systems.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | CG MedTech Co., Ltd., South Korea |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K251725 |
| Record published | 2025-07-10 |
| Record revised | 2025-01-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS2114CR | In distribution | |
| OS2013CC | In distribution | |
| OS2115CR | In distribution | |
| OS2008CC | In distribution | |
| OS2009CC | In distribution | |
| OS2007CC | In distribution | |
| OS2002CC | In distribution | |
| OS2006CR | In distribution | |
| OS2210CR | In distribution | |
| OS2001CC | In distribution | |
| OS2015CR | In distribution | |
| OS2008CR | In distribution | |
| OS2007CR | In distribution | |
| OS0921 | In distribution | |
| OS2010CR | In distribution | |
| OS2002CR | In distribution | |
| OS2012CC | In distribution | |
| OS2003CC | In distribution | |
| OS2124CR | In distribution | |
| OS2113CR | In distribution | |
| OS2111CR | In distribution | |
| OS2009CR | In distribution | |
| OS2005CR | In distribution | |
| OS2006CC | In distribution | |
| OS2012CR | In distribution | |
| OS2125CR | In distribution | |
| OS2011CC | In distribution | |
| OS2005CC | In distribution | |
| OS2112CR | In distribution | |
| OS2010CC | In distribution | |
| OS2004CR | In distribution | |
| OS2123CR | In distribution | |
| OS2122CR | In distribution | |
| OS2121CR | In distribution | |
| OS2014CR | In distribution | |
| OS2004CC | In distribution | |
| OS2013CR | In distribution | |
| OS2011CR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251725 | 2025-06-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.