Thunderbolt
Thunderbolt,x-TAB SCREW,10.5X100X120
15manufacturers in China registered for this device type
300catalogue 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 | Choice Spine, LP |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K171456 |
| Record published | 2023-07-06 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MT11-60100-080 | In distribution | |
| MT11-6535-120 | In distribution | |
| MT11-8560-120 | In distribution | |
| MT11-6535-080 | In distribution | |
| MT11-9550-120 | In distribution | |
| MT11-6550-120 | In distribution | |
| MT11-5025-080 | In distribution | |
| MT11-7590-080 | In distribution | |
| MT11-10535-120 | In distribution | |
| MT11-10545-080 | In distribution | |
| MT11-8540-080 | In distribution | |
| MT11-7540-120 | In distribution | |
| MT11-4590-120 | In distribution | |
| MT11-6030-120 | In distribution | |
| MT11-7530-080 | In distribution | |
| MT11-5530-120 | In distribution | |
| MT11-5065-120 | In distribution | |
| MT11-6530-120 | In distribution | |
| MT11-7070-080 | In distribution | |
| MT11-7080-120 | In distribution | |
| MT11-10560-080 | In distribution | |
| MT11-5045-080 | In distribution | |
| MT11-8555-080 | In distribution | |
| MT11-8560-080 | In distribution | |
| MT11-105100-120 | In distribution | |
| MT11-6525-080 | In distribution | |
| MT11-5065-080 | In distribution | |
| MT11-6025-080 | In distribution | |
| MT11-45100-080 | In distribution | |
| MT11-6075-120 | In distribution | |
| MT11-9530-080 | In distribution | |
| MT11-6570-080 | In distribution | |
| MT11-5075-080 | In distribution | |
| MT11-60110-080 | In distribution | |
| MT11-7540-080 | In distribution | |
| MT11-45110-080 | In distribution | |
| MT11-8580-120 | In distribution | |
| MT11-5030-080 | In distribution | |
| MT11-70100-120 | In distribution | |
| MT11-5030-120 | In distribution | |
| MT11-6055-120 | In distribution | |
| MT11-5055-120 | In distribution | |
| MT11-6575-120 | In distribution | |
| MT11-10560-120 | In distribution | |
| MT11-5550-120 | In distribution | |
| MT11-7555-120 | In distribution | |
| MT11-7525-120 | In distribution | |
| MT11-4575-080 | In distribution | |
| MT11-7060-080 | In distribution | |
| MT11-4540-120 | In distribution | |
| MT11-8575-080 | In distribution | |
| MT11-4590-080 | In distribution | |
| MT11-5570-080 | In distribution | |
| MT11-75100-080 | In distribution | |
| MT11-9535-080 | In distribution | |
| MT11-6055-080 | In distribution | |
| MT11-105110-080 | In distribution | |
| MT11-7060-120 | In distribution | |
| MT11-65100-080 | In distribution | |
| MT11-7040-120 | In distribution | |
| MT11-6555-120 | In distribution | |
| MT11-6065-080 | In distribution | |
| MT11-9525-120 | In distribution | |
| MT11-5535-120 | In distribution | |
| MT11-5555-080 | In distribution | |
| MT11-6060-080 | In distribution | |
| MT11-9550-080 | In distribution | |
| MT11-6570-120 | In distribution | |
| MT11-10565-120 | In distribution | |
| MT11-4540-080 | In distribution | |
| MT11-7090-120 | In distribution | |
| MT11-5570-120 | In distribution | |
| MT11-6090-120 | In distribution | |
| MT11-4580-080 | In distribution | |
| MT11-5075-120 | In distribution | |
| MT11-9545-120 | In distribution | |
| MT11-7555-080 | In distribution | |
| MT11-5565-120 | In distribution | |
| MT11-9555-120 | In distribution | |
| MT11-50110-080 | In distribution | |
| MT11-6070-120 | In distribution | |
| MT11-9590-120 | In distribution | |
| MT11-4530-120 | In distribution | |
| MT11-7070-120 | In distribution | |
| MT11-9570-120 | In distribution | |
| MT11-9565-080 | In distribution | |
| MT11-8525-120 | In distribution | |
| MT11-7025-120 | In distribution | |
| MT11-6090-080 | In distribution | |
| MT11-9590-080 | In distribution | |
| MT11-5070-120 | In distribution | |
| MT11-7065-120 | In distribution | |
| MT11-5090-080 | In distribution | |
| MT11-5090-120 | In distribution | |
| MT11-9575-120 | In distribution | |
| MT11-6530-080 | In distribution | |
| MT11-10565-080 | In distribution | |
| MT11-6025-120 | In distribution | |
| MT11-4580-120 | In distribution | |
| MT11-60110-120 | In distribution | |
| MT11-50100-080 | In distribution | |
| MT11-6580-120 | In distribution | |
| MT11-8575-120 | In distribution | |
| MT11-6580-080 | In distribution | |
| MT11-5560-120 | In distribution | |
| MT11-10545-120 | In distribution | |
| MT11-5080-120 | In distribution | |
| MT11-6080-120 | In distribution | |
| MT11-6080-080 | In distribution | |
| MT11-6040-080 | In distribution | |
| MT11-8580-080 | In distribution | |
| MT11-6050-120 | In distribution | |
| MT11-5560-080 | In distribution | |
| MT11-4550-120 | In distribution | |
| MT11-10590-080 | In distribution | |
| MT11-7570-080 | In distribution | |
| MT11-9535-120 | In distribution | |
| MT11-7050-120 | In distribution | |
| MT11-6540-080 | In distribution | |
| MT11-5590-120 | In distribution | |
| MT11-7065-080 | In distribution | |
| MT11-5580-120 | In distribution | |
| MT11-9560-120 | In distribution | |
| MT11-7565-080 | In distribution | |
| MT11-105110-120 | In distribution | |
| MT11-75110-120 | In distribution | |
| MT11-5080-080 | In distribution | |
| MT11-6035-120 | In distribution | |
| MT11-6575-080 | In distribution | |
| MT11-7025-080 | In distribution | |
| MT11-6545-120 | In distribution | |
| MT11-50110-120 | In distribution | |
| MT11-4565-120 | In distribution | |
| MT11-75110-080 | In distribution | |
| MT11-4570-120 | In distribution | |
| MT11-7565-120 | In distribution | |
| MT11-55110-120 | In distribution | |
| MT11-7030-120 | In distribution | |
| MT11-6060-120 | In distribution | |
| MT11-4560-120 | In distribution | |
| MT11-10575-120 | In distribution | |
| MT11-10530-080 | In distribution | |
| MT11-7055-080 | In distribution | |
| MT11-6035-080 | In distribution | |
| MT11-10525-080 | In distribution | |
| MT11-7090-080 | In distribution | |
| MT11-8565-120 | In distribution | |
| MT11-9530-120 | In distribution | |
| MT11-5530-080 | In distribution | |
| MT11-7525-080 | In distribution | |
| MT11-55110-080 | In distribution | |
| MT11-10525-120 | In distribution | |
| MT11-5045-120 | In distribution | |
| MT11-10530-120 | In distribution | |
| MT11-5535-080 | In distribution | |
| MT11-6565-080 | In distribution | |
| MT11-5040-120 | In distribution | |
| MT11-7045-080 | In distribution | |
| MT11-6540-120 | In distribution | |
| MT11-85110-080 | In distribution | |
| MT11-7550-120 | In distribution | |
| MT11-4545-120 | In distribution | |
| MT11-5025-120 | In distribution | |
| MT11-8530-120 | In distribution | |
| MT11-5580-080 | In distribution | |
| MT11-4555-080 | In distribution | |
| MT11-9580-120 | In distribution | |
| MT11-7035-080 | In distribution | |
| MT11-4565-080 | In distribution | |
| MT11-7545-120 | In distribution | |
| MT11-9580-080 | In distribution | |
| MT11-5525-120 | In distribution | |
| MT11-5035-080 | In distribution | |
| MT11-6065-120 | In distribution | |
| MT11-8535-080 | In distribution | |
| MT11-105100-080 | In distribution | |
| MT11-7080-080 | In distribution | |
| MT11-55100-080 | In distribution | |
| MT11-9545-080 | In distribution | |
| MT11-60100-120 | In distribution | |
| MT11-10590-120 | In distribution | |
| MT11-95100-080 | In distribution | |
| MT11-4525-080 | In distribution | |
| MT11-5545-120 | In distribution | |
| MT11-5035-120 | In distribution | |
| MT11-7575-080 | In distribution | |
| MT11-95110-120 | In distribution | |
| MT11-65110-120 | In distribution | |
| MT11-6560-080 | In distribution | |
| MT11-5590-080 | In distribution | |
| MT11-5545-080 | In distribution | |
| MT11-5525-080 | In distribution | |
| MT11-8535-120 | In distribution | |
| MT11-7560-080 | In distribution | |
| MT11-10570-080 | In distribution | |
| MT11-7530-120 | In distribution | |
| MT11-10555-120 | In distribution | |
| MT11-5575-120 | In distribution | |
| MT11-10540-120 | In distribution | |
| MT11-6045-120 | In distribution | |
| MT11-5575-080 | In distribution | |
| MT11-6550-080 | In distribution | |
| MT11-8545-080 | In distribution | |
| MT11-7050-080 | In distribution | |
| MT11-7030-080 | In distribution | |
| MT11-9525-080 | In distribution | |
| MT11-7535-080 | In distribution | |
| MT11-10535-080 | In distribution | |
| MT11-8525-080 | In distribution | |
| MT11-8565-080 | In distribution | |
| MT11-70100-080 | In distribution | |
| MT11-10580-080 | In distribution | |
| MT11-6050-080 | In distribution | |
| MT11-7045-120 | In distribution | |
| MT11-9570-080 | In distribution | |
| MT11-6045-080 | In distribution | |
| MT11-4570-080 | In distribution | |
| MT11-7035-120 | In distribution | |
| MT11-95100-120 | In distribution | |
| MT11-75100-120 | In distribution | |
| MT11-7580-080 | In distribution | |
| MT11-5050-080 | In distribution | |
| MT11-6560-120 | In distribution | |
| MT11-6040-120 | In distribution | |
| MT11-10570-120 | In distribution | |
| MT11-8590-120 | In distribution | |
| MT11-5555-120 | In distribution | |
| MT11-7550-080 | In distribution | |
| MT11-8545-120 | In distribution | |
| MT11-4550-080 | In distribution | |
| MT11-7560-120 | In distribution | |
| MT11-9540-080 | In distribution | |
| MT11-8540-120 | In distribution | |
| MT11-4545-080 | In distribution | |
| MT11-10550-120 | In distribution | |
| MT11-10575-080 | In distribution | |
| MT11-85100-080 | In distribution | |
| MT11-6590-120 | In distribution | |
| MT11-5540-120 | In distribution | |
| MT11-9575-080 | In distribution | |
| MT11-4560-080 | In distribution | |
| MT11-7075-080 | In distribution | |
| MT11-6525-120 | In distribution | |
| MT11-55100-120 | In distribution | |
| MT11-4525-120 | In distribution | |
| MT11-5060-080 | In distribution | |
| MT11-7055-120 | In distribution | |
| MT11-4555-120 | In distribution | |
| MT11-70110-120 | In distribution | |
| MT11-4530-080 | 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
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.