Odalys
The Odalys is a pedicle screw spinal system.
13manufacturers in China registered for this device type
54catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Kisco International, France |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K152098 |
| Record published | 2015-11-02 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rod Ø5.5 L255 | In distribution | |
| Polyaxial screw Ø7 L40 | In distribution | |
| Polyaxial screw Ø6 L45 | In distribution | |
| Polyaxial screw Ø7 L55 | In distribution | |
| Polyaxial spondylolisthesis screw Ø5 L35 | In distribution | |
| Curved rod Ø5.5 L85 | In distribution | |
| Polyaxial spondylolisthesis screw Ø7 L30 | In distribution | |
| Polyaxial spondylolisthesis screw Ø5 L50 | In distribution | |
| Polyaxial spondylolisthesis screw Ø7 L45 | In distribution | |
| Rod Ø5.5 L225 | In distribution | |
| Polyaxial screw Ø5 L50 | In distribution | |
| Polyaxial spondylolisthesis screw Ø7 L50 | In distribution | |
| Polyaxial spondylolisthesis screw Ø6 L55 | In distribution | |
| Curved rod Ø5.5 L75 | In distribution | |
| Polyaxial screw Ø6 L30 | In distribution | |
| Polyaxial spondylolisthesis screw Ø5 L30 | In distribution | |
| Polyaxial screw Ø5 L30 | In distribution | |
| Transverse system L57-91 | In distribution | |
| Polyaxial screw Ø7 L50 | In distribution | |
| Polyaxial screw Ø6 L55 | In distribution | |
| Rod Ø5.5 L135 | In distribution | |
| Polyaxial spondylolisthesis screw Ø7 L55 | In distribution | |
| Polyaxial screw Ø5 L40 | In distribution | |
| Polyaxial spondylolisthesis screw Ø6 L50 | In distribution | |
| Transverse system L31-40 | In distribution | |
| Polyaxial screw Ø6 L40 | In distribution | |
| Curved rod Ø5.5 L35 | In distribution | |
| Polyaxial spondylolisthesis screw Ø5 L45 | In distribution | |
| Polyaxial spondylolisthesis screw Ø5 L40 | In distribution | |
| Transverse system L40-57 | In distribution | |
| Polyaxial screw Ø6 L50 | In distribution | |
| Polyaxial screw Ø5 L45 | In distribution | |
| Polyaxial screw Ø7 L35 | In distribution | |
| Curved rod Ø5.5 L95 | In distribution | |
| Polyaxial screw Ø7 L45 | In distribution | |
| Polyaxial screw Ø5 L55 | In distribution | |
| Polyaxial spondylolisthesis screw Ø6 L45 | In distribution | |
| Polyaxial screw Ø6 L35 | In distribution | |
| Rod Ø5.5 L155 | In distribution | |
| Polyaxial spondylolisthesis screw Ø5 L55 | In distribution | |
| Polyaxial spondylolisthesis screw Ø6 L35 | In distribution | |
| Polyaxial screw Ø7 L30 | In distribution | |
| Rod Ø5.5 L185 | In distribution | |
| Curved rod Ø5.5 L45 | In distribution | |
| Locking cap | In distribution | |
| Curved rod Ø5.5 L65 | In distribution | |
| Curved rod Ø5.5 L105 | In distribution | |
| Polyaxial spondylolisthesis screw Ø6 L40 | In distribution | |
| Polyaxial spondylolisthesis screw Ø7 L35 | In distribution | |
| Polyaxial screw Ø5 L35 | In distribution | |
| Curved rod Ø5.5 L55 | In distribution | |
| Polyaxial spondylolisthesis screw Ø7 L40 | In distribution | |
| Curved rod Ø5.5 L115 | In distribution | |
| Polyaxial spondylolisthesis screw Ø6 L30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152098 | 2015-09-17 |
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.