Nex-D2
HIGH-TOP POLYAXIAL CANNULATED SCREW, ST, Ø7.8mm x 100mm
13manufacturers in China registered for this device type
156catalogue numbers in this listing
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 | Next Orthosurgical, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K141291 |
| Record published | 2024-12-18 |
| Record revised | 2025-07-02 (version 2) |
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 | Length 20 to 150 mm; outer diameter 4.5 to 7.8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CBFDJ-65140 | Length 140 mm | In distribution |
| CBFDJ-45070 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55105 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-75030 | Length 30 mm | In distribution |
| CBFCJ-75140 | Outer Diameter 7.5 mm | In distribution |
| CBFDJ-45025 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-65130 | Length 130 mm | In distribution |
| CBFDJ-55105 | Length 105 mm | In distribution |
| CBFDJ-65135 | Length 135 mm | In distribution |
| CBFAJ-55130 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-65060 | Length 60 mm | In distribution |
| CBFCJ-75135 | Outer Diameter 7.5 mm | In distribution |
| CBFDJ-45115 | Length 115 mm | In distribution |
| CBFAJ-55060 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-65035 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-65055 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-55065 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-55040 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-65090 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-55140 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-65150 | Length 150 mm | In distribution |
| CBFAJ-55025 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-65060 | Outer Diameter 6.5 mm | In distribution |
| CBEBJ-55035 | In distribution | |
| CBFAJ-65110 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-45020 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55125 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-45110 | Length 110 mm | In distribution |
| CBFDJ-55090 | Length 90 mm | In distribution |
| CBFDJ-45085 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55140 | Length 140 mm | In distribution |
| CBFAJ-65050 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-55065 | Length 65 mm | In distribution |
| CBFAJ-45110 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55135 | Length 135 mm | In distribution |
| CBFAJ-55075 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-65020 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-55110 | Length 110 mm | In distribution |
| CBFDJ-45100 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55045 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-55085 | Length 85 mm | In distribution |
| CBFDJ-45125 | Length 125 mm | In distribution |
| CBFDJ-65040 | Length 40 mm | In distribution |
| CBFDJ-65045 | Length 45 mm | In distribution |
| CBFDJ-55035 | Length 35 mm | In distribution |
| CBFDJ-45130 | Length 130 mm | In distribution |
| CBFAJ-55080 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-55115 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-55070 | Length 70 mm | In distribution |
| CBDJJ-55095 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-55050 | Length 50 mm | In distribution |
| CBFAJ-65065 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-65090 | Length 90 mm | In distribution |
| CBFDJ-65080 | Length 80 mm | In distribution |
| CBFAJ-45125 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-45130 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-75025 | Length 25 mm | In distribution |
| CBFAJ-55110 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-65145 | Length 145 mm | In distribution |
| CBFDJ-65085 | Length 85 mm | In distribution |
| CBFDJ-45145 | Length 145 mm | In distribution |
| CBFDJ-55030 | Length 30 mm | In distribution |
| CBFDJ-45080 | Outer Diameter 4.5 mm | In distribution |
| CBDUJ-55085 | In distribution | |
| CBFAJ-65105 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-45095 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-65075 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-65070 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-45055 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55075 | Length 75 mm | In distribution |
| CBFDJ-65070 | Length 70 mm | In distribution |
| CBFAJ-55055 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-65055 | Length 55 mm | In distribution |
| CBFDJ-65095 | Length 95 mm | In distribution |
| CBFDJ-55095 | Length 95 mm | In distribution |
| CBFAJ-65125 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-65120 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-45105 | Length 105 mm | In distribution |
| CBFDJ-55150 | Length 150 mm | In distribution |
| CBFDJ-65020 | Length 20 mm | In distribution |
| CBFAJ-45140 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55060 | Length 60 mm | In distribution |
| CBFDJ-45150 | Length 150 mm | In distribution |
| CBFDJ-65065 | Length 65 mm | In distribution |
| CBFAJ-55100 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-45040 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-78100 | Outer Diameter 7.8 mm | In distribution |
| CBFCJ-75130 | Outer Diameter 7.5 mm | In distribution |
| CBFDJ-45030 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-65100 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-45075 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-45095 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55150 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-65075 | Length 75 mm | In distribution |
| CBFCJ-75145 | Outer Diameter 7.5 mm | In distribution |
| CBFDJ-65115 | Length 115 mm | In distribution |
| CBFDJ-45135 | Length 135 mm | In distribution |
| CBFDJ-65030 | Length 30 mm | In distribution |
| CBFAJ-65080 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-45065 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-65120 | Length 120 mm | In distribution |
| CBFDJ-65035 | Length 35 mm | In distribution |
| CBFDJ-55120 | Length 120 mm | In distribution |
| CBFDJ-45090 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-75020 | Length 20 mm | In distribution |
| CBFAJ-45115 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55145 | Length 145 mm | In distribution |
| CBFDJ-65110 | Length 110 mm | In distribution |
| CBFAJ-55095 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-55100 | Length 100 mm | In distribution |
| CBFAJ-55035 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-45050 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-45135 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55030 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-55050 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-55130 | Length 130 mm | In distribution |
| CBFAJ-45100 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-65040 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-55070 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-45120 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55085 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-55090 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-45035 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-45140 | Length 140 mm | In distribution |
| CBFAJ-65115 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-55025 | Length 25 mm | In distribution |
| CBFAJ-65095 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-45090 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55040 | Length 40 mm | In distribution |
| CBFDJ-65125 | Length 125 mm | In distribution |
| CBFDJ-55020 | Length 20 mm | In distribution |
| CBFAJ-55120 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-55020 | Outer Diameter 5.5 mm | In distribution |
| CBFDJ-45120 | Length 120 mm | In distribution |
| CBFAJ-65030 | Outer Diameter 6.5 mm | In distribution |
| CBFCJ-75150 | Outer Diameter 7.5 mm | In distribution |
| CBFDJ-55080 | Length 80 mm | In distribution |
| CBFDJ-65105 | Length 105 mm | In distribution |
| CBFDJ-55125 | Length 125 mm | In distribution |
| CBFDJ-65050 | Length 50 mm | In distribution |
| CBFDJ-55115 | Length 115 mm | In distribution |
| CBFAJ-55145 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-45105 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-55135 | Outer Diameter 5.5 mm | In distribution |
| CBFAJ-45145 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-45150 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-55045 | Length 45 mm | In distribution |
| CBFDJ-45045 | Outer Diameter 4.5 mm | In distribution |
| CBFDJ-65025 | Length 25 mm | In distribution |
| CBFDJ-45060 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-65045 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-55055 | Length 55 mm | In distribution |
| CBFAJ-65085 | Outer Diameter 6.5 mm | In distribution |
| CBFAJ-45085 | Outer Diameter 4.5 mm | In distribution |
| CBFAJ-65025 | Outer Diameter 6.5 mm | In distribution |
| CBFDJ-65100 | Length 100 mm | 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
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.