Diplomat
332 catalogue numbers from Rod, curved, listed by Signus Medizintechnik Gmbh, Germany, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
332catalogue numbers in this listing
1510(k) clearance
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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Signus Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K151704 |
| Record published | 2016-06-16 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rod, curved | Ø5.5x100mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x75mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø6.5x30mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x55mm | In distribution |
| Cross connector S | 29-38mm | In distribution |
| Rod, straight | Ø5.5x250mm | In distribution |
| Rod, straight | Ø5.5x240mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x40mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø8,5x25mm | In distribution |
| Rod, curved | Ø5.5x105mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x50mm | In distribution |
| Parallel connector CC | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x50mm | In distribution |
| Rod, straight | Ø5.5x35mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x60mm | In distribution |
| Rod, curved | Ø5.5x90mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø5.5x55mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x80mm | In distribution |
| Rod, curved | Ø5.5x55mm | In distribution |
| Rod, curved | Ø5.5x80mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x70mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x90mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x90mm | In distribution |
| Rod, straight | Ø5.5x270mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x50mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x60mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø5.5x40mm | In distribution |
| Rod, curved | Ø5.5x75mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x55mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x45mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x65mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x65mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x35mm | In distribution |
| Rod, straight | Ø5.5x45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x50mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x90mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x80mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø6.5x45mm | In distribution |
| Offset connector closed, incl. set screw | Ø5,5x20mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x70mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9,5x35mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø5.5x50mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x35mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial, incl. set screw | Ø4.5x50mm | In distribution |
| Rod, straight, hex connector | Ø5.5x500mm,SW5 | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x75mm | In distribution |
| Parallel connector UU, incl. set screws | Ø6,0mm/5,5mm, L20mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x70mm | In distribution |
| Rod, curved | Ø5.5x70mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9,5x30mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x65mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x45mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x35mm | In distribution |
| Rod, curved | Ø5.5x85mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø5.5x50mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x90mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial | Ø5.5x30mm | In distribution |
| Offset connector closed, incl. set screw | Ø5,5x30mm | In distribution |
| Parallel connector CC | Ø5,5mm/6,0mm | In distribution |
| Offset connector closed, incl. set screw | Ø5,5x40mm | In distribution |
| Pedicle screw, cannulated, monoaxial | Ø4.5x45mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x55mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø5.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x40mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø7.5x25mm | In distribution |
| Cross connector M | 36-52mm | In distribution |
| Rod, curved | Ø5.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x50mm | In distribution |
| Rod, curved | Ø5.5x140mm | In distribution |
| Rod, curved | Ø5.5x30mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x80mm | In distribution |
| Parallel connector UU, incl. set screws | Ø5,5mm/5,5mm, L11mm | In distribution |
| Cross connector L | 54-82mm | In distribution |
| Rod, curved | Ø5.5x120mm | In distribution |
| Parallel connector UU, incl. set screws | Ø4,5mm/5,5mm, L20mm | In distribution |
| Offset connector open, incl. set screw | Ø5,5x15mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x60mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø5.5x40mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x60mm | In distribution |
| Parallel connector OC | Ø6,0mm/5,5mm | In distribution |
| Parallel connector OC | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø6.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x90mm | In distribution |
| Pedicle screw, fenestrated, monoaxial, incl. set screw | Ø5.5x30mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x70mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x45mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x60mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x30mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø5.5x35mm | In distribution |
| Rod, straight | Ø5.5x200mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x40mm | In distribution |
| Offset connector open, incl. set screw | Ø5,5x40mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x75mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x40mm | In distribution |
| Cross connector M | 41-58mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x100mm | In distribution |
| Rod, straight | Ø5.5x260mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8,5x30mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x55mm | In distribution |
| Rod, straight | Ø5.5x30mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x60mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x45mm | In distribution |
| Rod, straight | Ø5.5x110mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x65mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x35mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x55mm | In distribution |
| Set screw for offset connector | In distribution | |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x60mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x50mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø6.5x55mm | In distribution |
| Parallel connector OO | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x80mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x45mm | In distribution |
| Parallel connector UU, incl. set screws | Ø6,0mm/5,5mm, L15mm | In distribution |
| Rod, curved | Ø5.5x130mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x70mm | In distribution |
| Parallel connector OO | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x65mm | In distribution |
| Offset connector | Ø5,5x15mm | In distribution |
| Rod, curved | Ø5.5x35mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x65mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x40mm | In distribution |
| Rod, curved | Ø5.5x95mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x60mm | In distribution |
| Rod, straight | Ø5.5x75mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x60mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x80mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x50mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø6.5x25mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x65mm | In distribution |
| Pedicle screw w/o tulip for VB-fractures, cannulated, polyaxial | Ø4.5x25mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x45mm | In distribution |
| Rod, straight | Ø5.5x290mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x100mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x100mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø8.5x100mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x55mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x35mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x50mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x100mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x30mm | In distribution |
| Rod, curved | Ø5.5x40mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x50mm | In distribution |
| Rod, straight | Ø5.5x140mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x60mm | In distribution |
| Parallel connector UU, incl. set screws | Ø6,0mm/5,5mm, L11mm | In distribution |
| Parallel connector UC, incl. set screw | Ø5,5mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x80mm | In distribution |
| Rod, straight | Ø5.5x55mm | In distribution |
| Set screw T30 | Ø9.7×4.2mm | In distribution |
| Offset connector | Ø5,5x25mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x60mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x65mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x50mm | In distribution |
| Rod, straight | Ø5.5x70mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x60mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x55mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x55mm | In distribution |
| Rod, straight | Ø5.5x115mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x90mm | In distribution |
| Pedicle screw, cannulated, monoaxial | Ø4.5x40mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial, incl. set screw | Ø4.5x45mm | In distribution |
| Rod, straight | Ø5.5x125mm | In distribution |
| Rod, straight | Ø5.5x130mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x40mm | In distribution |
| Rod, straight | Ø5.5x150mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x55mm | In distribution |
| Pedicle screw, cannulated, monoaxial, incl. set screw | Ø4.5x30mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø6.5x35mm | In distribution |
| Rod, curved | Ø5.5x60mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x45mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x75mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x60mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x70mm | In distribution |
| Rod, straight | Ø5.5x105mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x90mm | In distribution |
| Offset connector closed, incl. set screw | Ø5,5x35mm | In distribution |
| Offset connector open, incl. set screw | Ø5,5x25mm | In distribution |
| Cross connector S | 35-45mm | In distribution |
| Rod, straight | Ø5.5x120mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x55mm | In distribution |
| Parallel connector UO, incl. set screw | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø5.5x30mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x75mm | In distribution |
| Parallel connector UO, incl. set screw | Ø6,0mm/5,5mm | In distribution |
| Rod, straight | Ø5.5x50mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x45mm | In distribution |
| Rod, straight | Ø5.5x400mm | In distribution |
| Rod, straight | Ø5.5x170mm | In distribution |
| Rod, curved | Ø5.5x110mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø5.5x45mm | In distribution |
| Pedicle screw, cannulated, monoaxial | Ø4.5x35mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x50mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø8.5x65mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø6.5x65mm | In distribution |
| Rod, curved | Ø5.5x45mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x30mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x40mm | In distribution |
| Rod, curved | Ø5.5x125mm | In distribution |
| Rod, straight | Ø5.5x280mm | In distribution |
| Cross connector XS | 25-31mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x45mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø5.5x60mm | In distribution |
| Rod, straight | Ø5.5x95mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø6.5x55mm | In distribution |
| Rod, straight | Ø5.5x300mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x75mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x65mm | In distribution |
| Rod, curved | Ø5.5x65mm | In distribution |
| Pedicle screw, cannulated, reduction, monoaxial, incl. set screw | Ø4.5x60mm | In distribution |
| Rod, straight | Ø5.5x80mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø6.5x30mm | In distribution |
| Rod, straight | Ø5.5x100mm | In distribution |
| Rod, straight | Ø5.5x180mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x100mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x45mm | In distribution |
| Parallel connector OC | Ø5,5mm/6,0mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø7.5x65mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x55mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø9.5x70mm | In distribution |
| Parallel connector UC, incl. set screw | Ø5,5mm/6,0mm | In distribution |
| Tulip | Ø12.5×14.9mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x55mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø9.5x80mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø8.5x60mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x65mm | In distribution |
| Parallel connector UC, incl. set screw | Ø6,0mm/5,5mm | In distribution |
| Pedicle screw, fenestrated, monoaxial | Ø7.5x70mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø9.5x90mm | In distribution |
| Pedicle screw w/o tulip, fenestrated, polyaxial | Ø9.5x70mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø4.5x30mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x45mm | In distribution |
| Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw | Ø7.5x55mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø8.5x70mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø6.5x65mm | In distribution |
| Pedicle screw, cannulated, monoaxial | Ø4.5x50mm | In distribution |
| Pedicle screw w/o tulip, cannulated, polyaxial | Ø4.5x30mm | In distribution |
| Pedicle screw w/o tulip, polyaxial | Ø7.5x45mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061577 | 2006-09-14 |
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.