Statyx™
AxT, 18H x 30W x 20°, Ti 6Al 4V (ELI)
3manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K162236 |
| Record published | 2025-09-30 |
| Record revised | 2025-12-22 (version 3) |
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 |
| Sizes | Height 10 to 20 mm; width 30 to 40 mm; angle 8 to 30 ° |
| Distribution end date | 2025-12-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AXT183020 | Height 18 mm | In distribution |
| AXT143020 | Height 14 mm | In distribution |
| AXT203014 | Height 20 mm | In distribution |
| AXT203614 | Height 20 mm | In distribution |
| AXT123614 | Height 12 mm | In distribution |
| AXT183620 | Height 18 mm | In distribution |
| AXT184008 | Height 18 mm | In distribution |
| AXT103008 | Height 10 mm | In distribution |
| AXT183030 | Height 18 mm | In distribution |
| AXT163620 | Height 16 mm | In distribution |
| AXT183014 | Height 18 mm | In distribution |
| AXT204014 | Height 20 mm | In distribution |
| AXT183608 | Height 18 mm | In distribution |
| AXT163014 | Height 16 mm | In distribution |
| AXT203008 | Height 20 mm | In distribution |
| AXT144008 | Height 14 mm | In distribution |
| AXT184014 | Height 18 mm | In distribution |
| AXT203620 | Height 20 mm | In distribution |
| AXT143014 | Height 14 mm | In distribution |
| AXT144014 | Height 14 mm | In distribution |
| AXT204008 | Height 20 mm | In distribution |
| AXT163020 | Height 16 mm | In distribution |
| AXT203030 | Height 20 mm | In distribution |
| AXT104008 | Height 10 mm | In distribution |
| AXT123014 | Height 12 mm | In distribution |
| AXT164008 | Height 16 mm | In distribution |
| AXT183614 | Height 18 mm | In distribution |
| AXT204020 | Height 20 mm | In distribution |
| AXT124008 | Height 12 mm | In distribution |
| AXT103014 | Height 10 mm | In distribution |
| AXT163008 | Height 16 mm | In distribution |
| AXT203020 | Height 20 mm | In distribution |
| AXT184020 | Height 18 mm | In distribution |
| AXT203608 | Height 20 mm | In distribution |
| AXT163608 | Height 16 mm | In distribution |
| AXT124014 | Height 12 mm | In distribution |
| AXT164014 | Height 16 mm | In distribution |
| AXT123008 | Height 12 mm | In distribution |
| AXT183008 | Height 18 mm | In distribution |
| AXT143008 | Height 14 mm | In distribution |
| AXT143608 | Height 14 mm | In distribution |
| AXT123608 | Height 12 mm | In distribution |
| AXT103608 | Height 10 mm | In distribution |
| AXT143614 | Height 14 mm | In distribution |
| AXT163614 | Height 16 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
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.