Opteryx®
65 catalogue numbers from CI-012, listed by Inno-Health Technology Co., Ltd., Taiwan, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
65catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Record published | 2018-01-31 |
| Record revised | 2025-12-31 (version 10) |
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, serial number |
| Sizes | Length 12 to 80 mm; outer diameter 4 to 4.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CI-012 | In distribution | |
| CP30 | Length 30 mm | In distribution |
| CP68 | Length 68 mm | In distribution |
| CP14 | Length 14 mm | In distribution |
| CP24 | Length 24 mm | In distribution |
| CI-030 | In distribution | |
| CP2020 | Outer Diameter 4.0 mm | In distribution |
| CP2218 | Outer Diameter 4.5 mm | In distribution |
| CP74 | Length 74 mm | In distribution |
| CP2017 | Outer Diameter 4.0 mm | In distribution |
| CP77 | Length 77 mm | In distribution |
| CP2112 | Outer Diameter 4.0 mm | In distribution |
| CP44 | Length 44 mm | In distribution |
| CP26 | Length 26 mm | In distribution |
| CI-090 | In distribution | |
| CP18 | Length 18 mm | In distribution |
| CP2113 | Outer Diameter 4.0 mm | In distribution |
| CP71 | Length 71 mm | In distribution |
| CP80 | Length 80 mm | In distribution |
| CP2119 | Outer Diameter 4.0 mm | In distribution |
| CP20 | Length 20 mm | In distribution |
| CI-100 | In distribution | |
| CP2115 | Outer Diameter 4.0 mm | In distribution |
| CP32 | Length 32 mm | In distribution |
| CP2320 | Outer Diameter 4.5 mm | In distribution |
| CP2019 | Outer Diameter 4.0 mm | In distribution |
| CP2312 | Outer Diameter 4.5 mm | In distribution |
| CI-110 | In distribution | |
| CI-010 | In distribution | |
| CP12 | Length 12 mm | In distribution |
| CP2116 | Outer Diameter 4.0 mm | In distribution |
| CP2117 | Outer Diameter 4.0 mm | In distribution |
| CP50 | Length 50 mm | In distribution |
| CP2214 | Outer Diameter 4.5 mm | In distribution |
| CP62 | Length 62 mm | In distribution |
| CP22 | Length 22 mm | In distribution |
| CP2012 | Length 12 mm | In distribution |
| CP2114 | Outer Diameter 4.0 mm | In distribution |
| CP2120 | Outer Diameter 4.0 mm | In distribution |
| CP2216 | Outer Diameter 4.5 mm | In distribution |
| CP2316 | Outer Diameter 4.5 mm | In distribution |
| CP59 | Length 59 mm | In distribution |
| CP2016 | Outer Diameter 4.0 mm | In distribution |
| CI-040 | In distribution | |
| CP34 | Length 34 mm | In distribution |
| CP2318 | Outer Diameter 4.5 mm | In distribution |
| CP16 | Length 16 mm | In distribution |
| CP53 | Length 53 mm | In distribution |
| CP38 | Length 38 mm | In distribution |
| CP2212 | Outer Diameter 4.5 mm | In distribution |
| CP41 | Length 41 mm | In distribution |
| CP2014 | Outer Diameter 4.0 mm | In distribution |
| CP2314 | Outer Diameter 4.5 mm | In distribution |
| CP2013 | Outer Diameter 4.0 mm | In distribution |
| CP2118 | Outer Diameter 4.0 mm | In distribution |
| CI-050 | In distribution | |
| CP56 | Length 56 mm | In distribution |
| CP2015 | Outer Diameter 4.0 mm | In distribution |
| CP28 | Length 28 mm | In distribution |
| CI-031 | In distribution | |
| CP2018 | Outer Diameter 4.0 mm | In distribution |
| CP2220 | Outer Diameter 4.5 mm | In distribution |
| CP47 | Length 47 mm | In distribution |
| CI-060 | In distribution | |
| CP36 | Length 36 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
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.