Thoracolumbosacral Pedicle Screw System
8.0MM Dual-Opening Screw 80MM Thread Length FOR 6.0MM Rods
15manufacturers in China registered for this device type
76catalogue numbers in this listing
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 | Synthes (U.S.A.) LP |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K092929 |
| Record published | 2015-09-14 |
| Record revised | 2026-06-30 (version 6) |
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 |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04.616.135 | Withdrawn | ||
| 298.038 | Withdrawn | ||
| 497.175 | Withdrawn | ||
| 497.167 | Withdrawn | ||
| 298.225 | Withdrawn | ||
| 299.233 | Withdrawn | ||
| 298.755 | Withdrawn | ||
| 298.402 | Withdrawn | ||
| 298.276 | Withdrawn | ||
| 497.165A | Withdrawn | ||
| 298.301 | Withdrawn | ||
| 297.877 | Withdrawn | ||
| 298.191 | Withdrawn | ||
| 497.873 | Withdrawn | ||
| 299.250 | Withdrawn | ||
| 299.221 | Withdrawn | ||
| 498.960 | Withdrawn | ||
| 299.289 | Withdrawn | ||
| 299.232 | Withdrawn | ||
| 299.247 | Withdrawn | ||
| 497.173A | Withdrawn | ||
| 299.260 | Withdrawn | ||
| 298.331 | Withdrawn | ||
| 297.875 | Withdrawn | ||
| 298.273 | Withdrawn | ||
| 298.046 | Withdrawn | ||
| 298.735 | Withdrawn | ||
| 02.621.010 | Withdrawn | ||
| 298.454 | Withdrawn | ||
| 298.407 | Withdrawn | ||
| 299.210 | Withdrawn | ||
| 297.796 | Withdrawn | ||
| 299.207 | Withdrawn | ||
| 497.872 | Withdrawn | ||
| 298.423 | Withdrawn | ||
| 04.650.023 | Withdrawn | ||
| 298.452 | Withdrawn | ||
| 298.862 | Withdrawn | ||
| 298.229 | Withdrawn | ||
| 298.382 | Withdrawn | ||
| 298.036 | Withdrawn | ||
| 299.265 | Withdrawn | ||
| 298.179 | Withdrawn | ||
| 298.401 | Withdrawn | ||
| 298.412 | Withdrawn | ||
| 497.789 | 5 | Withdrawn | |
| 298.750 | Withdrawn | ||
| 497.137 | Withdrawn | ||
| 299.231 | Withdrawn | ||
| 299.211 | Withdrawn | ||
| 298.864 | Withdrawn | ||
| 298.171 | Withdrawn | ||
| 04.633.305 | Withdrawn | ||
| 297.871 | Withdrawn | ||
| 298.047 | Withdrawn | ||
| 298.031 | Withdrawn | ||
| 04.631.055 | Withdrawn | ||
| 298.455 | Withdrawn | ||
| 298.880 | Withdrawn | ||
| 299.248 | Withdrawn | ||
| 497.172A | Withdrawn | ||
| 298.884 | Withdrawn | ||
| 297.873 | Withdrawn | ||
| 298.645 | Withdrawn | ||
| 298.760 | Withdrawn | ||
| 497.174 | Withdrawn | ||
| 04.650.021 | Withdrawn | ||
| 04.651.700 | Withdrawn | ||
| 04.631.060 | Withdrawn | ||
| 299.225 | Withdrawn | ||
| 04.651.730 | Withdrawn | ||
| 499.453 | Withdrawn | ||
| 298.302 | Withdrawn | ||
| 497.880 | Withdrawn | ||
| 04.631.070 | Withdrawn | ||
| 497.181A | Withdrawn |
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
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-07 | Class II | Use error | This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential | 757 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-07 | Class II | Use error | This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential | 745 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-06-18 | Class II | Labeling design | Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this | 1602 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2011-03-11 | Not classified | Labeling Change Control | Labeling Correction — The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolonga | 2014-12-18 |
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.