Pedicle Screw
Cannulated Modular Pedicle Screw 5.0 X 35
15manufacturers in China registered for this device type
67catalogue 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 | Eisertech, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2018-04-11 |
| 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 |
|---|---|---|
| 100320-5545D | In distribution | |
| 100196-55080150 | In distribution | |
| 100320-7580D | In distribution | |
| 100180-55095 | In distribution | |
| 100180-55055 | In distribution | |
| 100002-5035C | In distribution | |
| 100002-4530C | In distribution | |
| 100002-7530C | In distribution | |
| 100320-4525D | In distribution | |
| 100002-6525C | In distribution | |
| 100002-6025C | In distribution | |
| 100003-0 | In distribution | |
| 100320-8540D | In distribution | |
| 100196-55030150 | In distribution | |
| 100320-5555D | In distribution | |
| 100180-55045 | In distribution | |
| 100002-5535C | In distribution | |
| 100180-55075 | In distribution | |
| 100320-4535D | In distribution | |
| 100320-5525D | In distribution | |
| 100320-6560D | In distribution | |
| 100180-55065 | In distribution | |
| 100002-7045C | In distribution | |
| 100320-7545D | In distribution | |
| 100320-7525D | In distribution | |
| 100002-7025C | In distribution | |
| 100002-6055C | In distribution | |
| 100002-7555C | In distribution | |
| 100002-6045C | In distribution | |
| 100196-55070150 | In distribution | |
| 100002-5545C | In distribution | |
| 100180-55035 | In distribution | |
| 100320-4560D | In distribution | |
| 100196-55060150 | In distribution | |
| 100196-55100150 | In distribution | |
| 100320-8560D | In distribution | |
| 100320-6570D | In distribution | |
| 100002-5055C | In distribution | |
| 100002-5555C | In distribution | |
| 100002-6555C | In distribution | |
| 100320-4545D | In distribution | |
| 100196-55090150 | In distribution | |
| 100180-55085 | In distribution | |
| 100196-55120150 | In distribution | |
| 100002-6035C | In distribution | |
| 100002-6545C | In distribution | |
| 100002-7535C | In distribution | |
| 100320-6530D | In distribution | |
| 100320-7555D | In distribution | |
| 100002-5525C | In distribution | |
| 100320-8580D | In distribution | |
| 100002-7055C | In distribution | |
| 100002-6535C | In distribution | |
| 100196-55050150 | In distribution | |
| 100002-5045C | In distribution | |
| 100320-7535D | In distribution | |
| 100320-8550D | In distribution | |
| 100320-6550D | In distribution | |
| 100196-55040150 | In distribution | |
| 100002-7035C | In distribution | |
| 100320-4555D | In distribution | |
| 100180-55100 | In distribution | |
| 100320-6540D | In distribution | |
| 100180-55120 | In distribution | |
| 100320-5535D | In distribution | |
| 100320-7570D | In distribution | |
| 100002-7545C | In distribution |
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 |
|---|---|
| K142576 | 2015-02-26 |
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.