Ellipse
3.5mm (200mm) – 6.35mm (600mm) Tapered Rod, Cobalt Chrome, 800mm Length
11manufacturers in China registered for this device type
150catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K123783 |
| Record published | 2015-11-06 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Length 5 to 800 mm; outer diameter 3.5 to 6.5 mm; height 3 to 9 mm; angle 45 to 130 °; lumen/inner diameter 3.5 to 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 182.510 | Length 10 mm | In distribution |
| 182.801 | Length 80 mm | In distribution |
| 182.952 | Length 23.5 mm | In distribution |
| 782.945 | Outer Diameter 6.35 mm | In distribution |
| 182.242 | Outer Diameter 3.5 mm | In distribution |
| 182.491 | Height 9 mm | In distribution |
| 182.747 | Length 8 mm | In distribution |
| 582.410 | Length 10 mm | In distribution |
| 182.514 | Outer Diameter 4.5 mm | In distribution |
| 182.831 | Outer Diameter 6.35 mm | In distribution |
| 182.489 | Height 5 mm | In distribution |
| 782.981 | Length 350 mm | In distribution |
| 182.496 | Height 3 mm | In distribution |
| 182.913 | Length 33 mm | In distribution |
| 182.946 | Length 800 mm | In distribution |
| 182.014 | Outer Diameter 3.5 mm | In distribution |
| 182.436 | Outer Diameter 4 mm | In distribution |
| 782.805 | Length 500 mm | In distribution |
| 182.412 | Outer Diameter 4 mm | In distribution |
| 182.418 | Outer Diameter 4 mm | In distribution |
| 182.923 | Length 21 mm | In distribution |
| 582.308 | Length 8 mm | In distribution |
| 182.016 | Outer Diameter 3.5 mm | In distribution |
| 182.975 | In distribution | |
| 182.308 | Length 8 mm | In distribution |
| 182.414 | Outer Diameter 4 mm | In distribution |
| 182.942 | Outer Diameter 5 mm | In distribution |
| 782.986 | Outer Diameter 6.5 mm | In distribution |
| 182.830 | Outer Diameter 6.35 mm | In distribution |
| 182.775 | Length 10 mm | In distribution |
| 782.946 | Outer Diameter 6.5 mm | In distribution |
| 182.987 | Length 350 mm | In distribution |
| 182.540 | Length 40 mm | In distribution |
| 182.992 | Angle 45 ° | In distribution |
| 182.416 | Outer Diameter 4 mm | In distribution |
| 182.832 | In distribution | |
| 182.448 | Outer Diameter 4 mm | In distribution |
| 782.802 | Length 120 mm | In distribution |
| 182.754 | Length 6.5 mm | In distribution |
| 782.953 | Angle 110 ° | In distribution |
| 182.944 | Outer Diameter 6 mm | In distribution |
| 182.805 | Length 500 mm | In distribution |
| 182.548 | Length 48 mm | In distribution |
| 182.977 | Length 700 mm | In distribution |
| 182.941 | Outer Diameter 4.75 mm | In distribution |
| 182.740 | Length 5.5 mm | In distribution |
| 782.804 | Length 40 mm | In distribution |
| 182.312 | Length 12 mm | In distribution |
| 182.542 | Length 42 mm | In distribution |
| 182.498 | Height 7 mm | In distribution |
| 182.532 | Outer Diameter 4.5 mm | In distribution |
| 182.495 | Height 9 mm | In distribution |
| 182.995 | Length 15 mm | In distribution |
| 182.763 | Lumen/Inner Diameter 5 mm | In distribution |
| 182.508 | Height 7 mm | In distribution |
| 582.310 | Outer Diameter 3.5 mm | In distribution |
| 182.509 | Height 5 mm | In distribution |
| 182.960 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 182.240 | Length 40 mm | In distribution |
| 182.018 | Length 18 mm | In distribution |
| 582.412 | Outer Diameter 4 mm | In distribution |
| 182.518 | Length 18 mm | In distribution |
| 182.967 | Lumen/Inner Diameter 6.5 mm | In distribution |
| 782.942 | Outer Diameter 5 mm | In distribution |
| 182.434 | Length 34 mm | In distribution |
| 182.526 | Length 26 mm | In distribution |
| 182.954 | Angle 115 ° | In distribution |
| 582.510 | Length 10 mm | In distribution |
| 182.430 | Outer Diameter 4 mm | In distribution |
| 782.979 | Outer Diameter 3.7 mm | In distribution |
| 182.314 | Outer Diameter 3.5 mm | In distribution |
| 182.538 | Outer Diameter 4.5 mm | In distribution |
| 182.326 | Length 26 mm | In distribution |
| 182.330 | Length 30 mm | In distribution |
| 182.444 | Outer Diameter 4 mm | In distribution |
| 782.977 | Outer Diameter 5.5 mm | In distribution |
| 182.833 | In distribution | |
| 182.956 | In distribution | |
| 782.801 | Length 80 mm | In distribution |
| 782.980 | Outer Diameter 4 mm | In distribution |
| 182.432 | Outer Diameter 4 mm | In distribution |
| 182.731 | Length 9 mm | In distribution |
| 182.226 | Length 26 mm | In distribution |
| 782.985 | Outer Diameter 6.35 mm | In distribution |
| 182.536 | Length 36 mm | In distribution |
| 182.410 | Outer Diameter 4 mm | In distribution |
| 182.986 | Length 350 mm | In distribution |
| 182.940 | Length 800 mm | In distribution |
| 182.316 | Outer Diameter 3.5 mm | In distribution |
| 182.446 | Outer Diameter 4 mm | In distribution |
| 582.312 | Outer Diameter 3.5 mm | In distribution |
| 182.770 | Length 9 mm | In distribution |
| 182.024 | Length 24 mm | In distribution |
| 182.450 | Outer Diameter 4 mm | In distribution |
| 182.428 | Outer Diameter 4 mm | In distribution |
| 182.520 | Outer Diameter 4.5 mm | In distribution |
| 182.022 | Outer Diameter 3.5 mm | In distribution |
| 182.501 | Height 6 mm | In distribution |
| 182.522 | Length 22 mm | In distribution |
| 182.945 | Length 800 mm | In distribution |
| 182.955 | Angle 130 ° | In distribution |
| 782.983 | Length 350 mm | In distribution |
| 782.987 | Outer Diameter 4.75 mm | In distribution |
| 182.516 | Outer Diameter 4.5 mm | In distribution |
| 182.915 | Length 45 mm | In distribution |
| 182.765 | Length 10 mm | In distribution |
| 182.324 | Length 24 mm | In distribution |
| 182.500 | In distribution | |
| 182.772 | Length 10 mm | In distribution |
| 182.733 | Length 10 mm | In distribution |
| 182.741 | Length 7 mm | In distribution |
| 182.950 | Length 19.5 mm | In distribution |
| 182.507 | Height 5 mm | In distribution |
| 182.901 | In distribution | |
| 182.822 | In distribution | |
| 182.764 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 182.328 | Length 28 mm | In distribution |
| 182.234 | Outer Diameter 3.5 mm | In distribution |
| 182.344 | Length 44 mm | In distribution |
| 182.774 | Length 9 mm | In distribution |
| 182.917 | Length 57 mm | In distribution |
| 782.940 | Length 800 mm | In distribution |
| 182.834 | In distribution | |
| 182.752 | Length 5 mm | In distribution |
| 782.989 | Length 500 mm | In distribution |
| 182.550 | Outer Diameter 4.5 mm | In distribution |
| 182.318 | Length 18 mm | In distribution |
| 782.944 | Outer Diameter 6 mm | In distribution |
| 182.981 | Outer Diameter 4.5 mm | In distribution |
| 182.224 | Length 24 mm | In distribution |
| 182.912 | Length 27 mm | In distribution |
| 182.773 | Length 10 mm | In distribution |
| 182.544 | Outer Diameter 4.5 mm | In distribution |
| 782.803 | Length 240 mm | In distribution |
| 782.941 | Length 800 mm | In distribution |
| 182.996 | Length 20 mm | In distribution |
| 782.955 | Angle 130 ° | In distribution |
| 182.943 | Length 800 mm | In distribution |
| 782.984 | Outer Diameter 6 mm | In distribution |
| 182.751 | Length 8 mm | In distribution |
| 182.348 | Length 48 mm | In distribution |
| 182.012 | Length 12 mm | In distribution |
| 782.954 | Angle 115 ° | In distribution |
| 782.982 | Length 350 mm | In distribution |
| 182.488 | Height 3 mm | In distribution |
| 782.943 | Length 800 mm | In distribution |
| 182.504 | Height 6 mm | In distribution |
| 182.534 | Length 34 mm | In distribution |
| 582.512 | Length 12 mm | In distribution |
| 182.771 | Length 9 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123783 | 2013-03-14 |
| K110963 | 2011-05-05 |
| K102195 | 2011-01-19 |
| K090565 | 2009-06-30 |
| K081906 | 2008-11-14 |
| K052069 | 2005-08-17 |
| K050391 | 2005-07-21 |
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.