Inertia® Pedicle Screw System
Reduction Pedicle Screw, Ø4.5mm x 35mm
11manufacturers in China registered for this device type
46catalogue numbers in this listing
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 | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K132412 |
| Record published | 2015-08-28 |
| Record revised | 2024-09-11 (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 20 to 90 mm; outer diameter 4.5 to 7.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-14-7580 | Length 80 mm | In distribution |
| 10-14-7530 | Length 30 mm | In distribution |
| 10-14-5540 | Length 40 mm | In distribution |
| 10-15-4535 | Length 35 mm | In distribution |
| 10-14-4545 | Length 45 mm | In distribution |
| 10-14-7550 | Length 50 mm | In distribution |
| 10-15-4525 | Length 25 mm | In distribution |
| 10-10-4525 | Length 25 mm | In distribution |
| 10-10-4545 | Length 45 mm | In distribution |
| 10-14-7040 | Length 40 mm | In distribution |
| 10-14-6560 | Length 60 mm | In distribution |
| 10-22-4540 | Outer Diameter 4.5 mm | In distribution |
| 10-14-7570 | Length 70 mm | In distribution |
| 10-10-4535 | Length 35 mm | In distribution |
| 10-14-7030 | Length 30 mm | In distribution |
| 10-14-6545 | Length 45 mm | In distribution |
| 10-14-7540 | Length 40 mm | In distribution |
| 10-14-5530 | Length 30 mm | In distribution |
| 10-10-4520 | Length 20 mm | In distribution |
| 10-15-4530 | Reduction | In distribution |
| 10-22-4530 | Outer Diameter 4.5 mm | In distribution |
| 10-10-4530 | Length 30 mm | In distribution |
| 10-14-7590 | Length 90 mm | In distribution |
| 10-22-4550 | Outer Diameter 4.5 mm | In distribution |
| 10-14-4525 | Length 25 mm | In distribution |
| 10-15-4545 | Length 45 mm | In distribution |
| 10-15-4540 | Reduction | In distribution |
| 10-14-4535 | Length 35 mm | In distribution |
| 10-14-6555 | Length 55 mm | In distribution |
| 10-14-7060 | Length 60 mm | In distribution |
| 10-14-4555 | Length 55 mm | In distribution |
| 10-15-4550 | Reduction | In distribution |
| 10-14-7080 | Length 80 mm | In distribution |
| 10-14-7560 | Length 60 mm | In distribution |
| 10-14-7050 | Length 50 mm | In distribution |
| 10-14-6525 | Length 25 mm | In distribution |
| 10-14-6535 | Length 35 mm | In distribution |
| 10-10-4555 | Length 55 mm | In distribution |
| 10-14-7070 | Length 70 mm | In distribution |
| 10-14-5550 | Length 50 mm | In distribution |
| 10-10-4540 | Length 40 mm | In distribution |
| 10-15-4520 | Outer Diameter 4.5 mm | In distribution |
| I10-02-25 | In distribution | |
| I10-33-02 | In distribution | |
| 10-15-4555 | Length 55 mm | In distribution |
| 10-10-4550 | Length 50 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
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.