Diplomat
349 catalogue numbers from Pedicle screw w/o tulip for VB-fractures, listed by Signus Medizintechnik Gmbh, Germany, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
349catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Signus Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K151704 |
| Record published | 2018-09-20 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 35 °C |
| Packaging | Pack of 2, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø9,5x25mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x70mm | In distribution |
| Rod, straight | Ø5.5x190mm | In distribution |
| Parallel connector | Ø5,5×5,5mm | In distribution |
| Offset connector closed | Ø5,5x25mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x40mm | In distribution |
| Rod, curved | Ø5.5x100mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x40mm | In distribution |
| Rod, curved | Ø5.5x80mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø8.5x75mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø6.5x50mm | In distribution |
| Offset connector open | Ø5,5x15mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x65mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial | Ø4.5x60mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x65mm | In distribution |
| Rod, curved | Ø5.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x30mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x65mm | In distribution |
| Rod, curved | Ø5.5x95mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x35mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x40mm | In distribution |
| Rod, straight | Ø5.5x160mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x40mm | In distribution |
| Bezeichnung Parallel connector OO | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø6.5x35mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x55mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø6.5x55mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x80mm | In distribution |
| Rod, straight | Ø5.5x100mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø6.5x65mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x55mm | In distribution |
| Offset connector closed | Ø5,5x40mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x40mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø9.5x55mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x40mm | In distribution |
| Rod, straight | Ø5.5x95mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x100mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x65mm | In distribution |
| Offset connector open | Ø5,5x40mm | In distribution |
| Parallel connector | Ø5,5×5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x40mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x60mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø5.5x55mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x55mm | In distribution |
| Pedicle screw, cannulated, monoaxial, incl. set screw | Ø4.5x40mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x55mm | In distribution |
| Parallel connector CC | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x60mm | In distribution |
| Parallel connector | Ø4,5×5,5mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x50mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x75mm | In distribution |
| Rod, straight | Ø5.5x80mm | In distribution |
| Rod, curved | Ø5.5x35mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø5.5x25mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x40mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x90mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x75mm | In distribution |
| Extension sleeve | Ø5,5mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x35mm | In distribution |
| Rod, straight | Ø5.5x450mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9,5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x60mm | In distribution |
| Rod, curved | Ø5.5x70mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x80mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x65mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø6.5x55mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x40mm | In distribution |
| Rod, straight | Ø5.5x130mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x55mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø6.5x35mm | In distribution |
| Pedicle screw, cannulated, monoaxial | Ø4.5x30mm | In distribution |
| Rod, straight | Ø5.5x270mm | In distribution |
| Parallel connector OC | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x75mm | In distribution |
| Parallel connector CC | Ø5,5mm/6,0mm | In distribution |
| Parallel connector OC | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø8.5x65mm | In distribution |
| Reduction tulip, incl. set screw | Ø12.5×32.2mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x60mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø5.5x60mm | In distribution |
| Rod, straight | Ø5.5x110mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x40mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø7.5x25mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø6.5x50mm | In distribution |
| Offset connector closed | Ø5,5x30mm | In distribution |
| Rod, straight | Ø5.5x60mm | In distribution |
| Rod, straight | Ø5.5x290mm | In distribution |
| Parallel connector | Ø6,0×5,5mm | In distribution |
| Offset connector | Ø5,5x20mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø6.5x40mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x30mm | In distribution |
| Parallel connector UU | Ø4,5mm/5,5mm, L20mm | In distribution |
| Rod, curved | Ø5.5x75mm | In distribution |
| Rod, straight | Ø5.5x240mm | In distribution |
| Offset connector | Ø5,5x30mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x45mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø5.5x40mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x60mm | In distribution |
| Parallel connector UU | Ø6,0mm/5,5mm, L20mm | In distribution |
| Parallel connector UC | Ø5,5mm/5,5mm | In distribution |
| Offset connector closed | Ø5,5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x55mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x90mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø6.5x65mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x90mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø8.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x45mm | In distribution |
| Inline connector OT | Ø5,5mm/5,5mm, L95mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø5.5x50mm | In distribution |
| Rod, straight | Ø5.5x70mm | In distribution |
| Parallel connector UU | Ø4,5mm/5,5mm, L11mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x65mm | In distribution |
| Offset connector open | Ø5,5x35mm | In distribution |
| Set screw T30 | Ø9.7×4.2mm | In distribution |
| Cross connector M | 36-52mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x90mm | In distribution |
| Percutaneous tulip, incl. set screw | Ø12.5x150mm | In distribution |
| Parallel connector UC | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8,5x35mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x50mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø9.5x40mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x40mm | In distribution |
| Rod, straight | Ø5.5x125mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x30mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x75mm | In distribution |
| Rod, curved | Ø5.5x85mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x80mm | In distribution |
| Pedicle screw, cannulated, monoaxial, incl. set screw | Ø4.5x50mm | In distribution |
| Rod, straight | Ø5.5x45mm | In distribution |
| Rod, curved | Ø5.5x150mm | In distribution |
| Parallel connector UU | Ø6,0mm/5,5mm, L11mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x75mm | In distribution |
| Parallel connector UU | Ø4,5mm/5,5mm, L15mm | In distribution |
| Parallel connector OC | Ø6,0mm/5,5mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x55mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø8.5x100mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8,5x30mm | In distribution |
| Rod, straight | Ø5.5x40mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x35mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x45mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø4.5x25mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x100mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x100mm | In distribution |
| Parallel connector UU | Ø5,5mm/5,5mm, L11mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø6.5x25mm | In distribution |
| Cross connector L | 50-77mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9,5x30mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x45mm | In distribution |
| Rod, straight | Ø5.5x115mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x100mm | In distribution |
| Rod, straight | Ø5.5x350mm | In distribution |
| Rod, straight | Ø5.5x30mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x30mm | In distribution |
| Rod, straight | Ø5.5x400mm | In distribution |
| Parallel connector UC | Ø6,0mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x80mm | In distribution |
| Rod, curved | Ø5.5x110mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial, incl. set screw | Ø4.5x30mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x60mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x60mm | In distribution |
| Rod, straight | Ø5.5x85mm | In distribution |
| Extension sleeve | Ø5,5mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial | Ø4.5x40mm | In distribution |
| Parallel connector UO | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø5.5x45mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x80mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x40mm | In distribution |
| Rod, straight | Ø5.5x180mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x50mm | In distribution |
| Rod, straight | Ø5.5x75mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x55mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø5.5x30mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x70mm | In distribution |
| Rod, curved | Ø5.5x65mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x45mm | In distribution |
| Pedicle screw, cannulated, monoaxial, incl. set screw | Ø4.5x45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x75mm | In distribution |
| Cross connector S | 29-38mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø9.5x70mm | In distribution |
| Parallel connector UO | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø8.5x80mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial | Ø4.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x65mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x65mm | In distribution |
| Rod, straight, hex connector | Ø5.5x500mm,SW5 | In distribution |
| Cross connector S | 35-45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x65mm | In distribution |
| Cross connector XL | 61-99mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x65mm | In distribution |
| Rod, straight | Ø5.5x65mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø8.5x45mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x60mm | In distribution |
| Rod, straight | Ø5.5x220mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø8.5x80mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x30mm | In distribution |
| Rod, curved | Ø5.5x140mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x45mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x40mm | In distribution |
| Rod, curved | Ø5.5x55mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x55mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x40mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x35mm | In distribution |
| Parallel connector | Ø6,0×5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x70mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x75mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x55mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x45mm | In distribution |
| Inline connector OT | Ø5,5mm/5,5mm, L95mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø9.5x45mm | In distribution |
| Parallel connector UO | Ø6,0mm/5,5mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x55mm | In distribution |
| Rod, curved | Ø5.5x125mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x50mm | In distribution |
| Pedicle screw, cannulated, monoaxial, incl. set screw | Ø4.5x35mm | In distribution |
| Rod, straight | Ø5.5x150mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø7.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x60mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x35mm | In distribution |
| Parallel connector UU | Ø6,0mm/5,5mm, L15mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x70mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø9.5x100mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x55mm | In distribution |
| Rod, curved | Ø5.5x40mm | In distribution |
| Rod, straight | Ø5.5x260mm | In distribution |
| Rod, curved | Ø5.5x105mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial | Ø4.5x35mm | In distribution |
| Rod, straight | Ø5.5x105mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x30mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x70mm | In distribution |
| Parallel connector OO | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø6.5x45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø7.5x100mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151704 | 2016-04-13 |
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.