Ellipse
ELLIPSE Top-Loading T-Connector for 3.5mm Rod, 36-56, Straight
4manufacturers in China registered for this device type
102catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Manufacturer, Exporter |
| Record published | 2015-11-06 |
| Record revised | 2025-07-02 (version 4) |
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 550 mm; outer diameter 3.5 to 6.35 mm; lumen/inner diameter 3.5 to 6.5 mm; height 3 to 9 mm; angle 100 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 182.732 | Length 6.75 mm | In distribution |
| 182.743 | Length 7 mm | In distribution |
| 182.826 | In distribution | |
| 182.222 | Length 22 mm | In distribution |
| 182.320 | Outer Diameter 3.5 mm | In distribution |
| 182.497 | Height 5 mm | In distribution |
| 182.776 | Length 9 mm | In distribution |
| 182.424 | Outer Diameter 4 mm | In distribution |
| 182.336 | Length 36 mm | In distribution |
| 182.829 | Outer Diameter 5.5 mm | In distribution |
| 182.823 | In distribution | |
| 182.993 | Length 15 mm | In distribution |
| 182.426 | Outer Diameter 4 mm | In distribution |
| 182.725 | In distribution | |
| 182.238 | Length 38 mm | In distribution |
| 182.332 | Outer Diameter 3.5 mm | In distribution |
| 182.730 | Length 6 mm | In distribution |
| 182.926 | Length 36 mm | In distribution |
| 182.927 | Length 36 mm | In distribution |
| 182.438 | Length 38 mm | In distribution |
| 182.442 | Outer Diameter 4 mm | In distribution |
| 182.985 | Length 350 mm | In distribution |
| 182.991 | Length 9 mm | In distribution |
| 182.964 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 182.232 | Length 32 mm | In distribution |
| 182.745 | Length 8 mm | In distribution |
| 182.420 | Outer Diameter 4 mm | In distribution |
| 182.748 | Length 5 mm | In distribution |
| 182.825 | In distribution | |
| 182.924 | Length 26 mm | In distribution |
| 182.346 | Outer Diameter 3.5 mm | In distribution |
| 182.914 | Length 39 mm | In distribution |
| 182.506 | Height 7 mm | In distribution |
| 182.916 | Length 51 mm | In distribution |
| 182.965 | Lumen/Inner Diameter 6 mm | In distribution |
| 182.750 | Length 6.5 mm | In distribution |
| 182.503 | Height 6 mm | In distribution |
| 182.953 | Angle 100 ° | In distribution |
| 182.322 | Length 22 mm | In distribution |
| 182.980 | Length 350 mm | In distribution |
| 182.749 | Length 7 mm | In distribution |
| 182.827 | In distribution | |
| 182.983 | Outer Diameter 5.5 mm | In distribution |
| 182.982 | Outer Diameter 5 mm | In distribution |
| 182.230 | Length 30 mm | In distribution |
| 182.228 | Outer Diameter 3.5 mm | In distribution |
| 182.835 | In distribution | |
| 182.777 | Length 10 mm | In distribution |
| 182.742 | Length 5.5 mm | In distribution |
| 182.762 | Length 10 mm | In distribution |
| 182.236 | Length 36 mm | In distribution |
| 182.966 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 182.989 | Length 500 mm | In distribution |
| 182.804 | Length 40 mm | In distribution |
| 182.821 | In distribution | |
| 182.350 | Length 50 mm | In distribution |
| 182.990 | Length 20 mm | In distribution |
| 182.310 | Outer Diameter 3.5 mm | In distribution |
| 182.010 | Length 10 mm | In distribution |
| 182.422 | Length 22 mm | In distribution |
| 182.755 | Length 8 mm | In distribution |
| 182.962 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 182.911 | Length 21 mm | In distribution |
| 182.026 | Outer Diameter 3.5 mm | In distribution |
| 182.766 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 182.334 | Outer Diameter 3.5 mm | In distribution |
| 182.020 | Outer Diameter 3.5 mm | In distribution |
| 182.490 | Height 7 mm | In distribution |
| 182.494 | Height 7 mm | In distribution |
| 182.492 | Height 3 mm | In distribution |
| 182.340 | Outer Diameter 3.5 mm | In distribution |
| 182.746 | Length 6.5 mm | In distribution |
| 182.744 | Length 6.5 mm | In distribution |
| 182.925 | Length 26 mm | In distribution |
| 182.528 | Length 28 mm | In distribution |
| 182.824 | In distribution | |
| 182.994 | Length 20 mm | In distribution |
| 182.803 | Length 240 mm | In distribution |
| 182.820 | In distribution | |
| 182.961 | Lumen/Inner Diameter 4 mm | In distribution |
| 182.724 | In distribution | |
| 182.440 | Outer Diameter 4 mm | In distribution |
| 182.900 | In distribution | |
| 182.802 | Length 120 mm | In distribution |
| 182.979 | Outer Diameter 3.7 mm | In distribution |
| 182.499 | Height 9 mm | In distribution |
| 182.524 | Length 24 mm | In distribution |
| 182.761 | Length 9 mm | In distribution |
| 182.493 | Height 5 mm | In distribution |
| 182.984 | Outer Diameter 6 mm | In distribution |
| 182.530 | Outer Diameter 4.5 mm | In distribution |
| 182.828 | Outer Diameter 5.5 mm | In distribution |
| 182.957 | In distribution | |
| 182.753 | Length 7 mm | In distribution |
| 182.342 | Length 42 mm | In distribution |
| 182.512 | Length 12 mm | In distribution |
| 182.963 | Lumen/Inner Diameter 5 mm | In distribution |
| 182.546 | Length 46 mm | In distribution |
| 182.988 | Outer Diameter 5.5 mm | In distribution |
| 182.760 | Length 9 mm | In distribution |
| 182.767 | Lumen/Inner Diameter 6.5 mm | In distribution |
| 182.338 | Length 38 mm | 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 |
|---|---|
| K231850 | 2024-03-14 |
| K211957 | 2021-08-18 |
| K161591 | 2016-09-21 |
| K150552 | 2015-06-04 |
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.