Zavation
K-wire, Blunt/Smooth, Blunt/Smooth/ Length 18.898
15manufacturers in China registered for this device type
1,084catalogue 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 | Zavation, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K190317 |
| Record published | 2020-04-03 |
| Record revised | 2025-02-06 (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, serial number |
| Distribution end date | 2024-01-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 350-4595-1 | In distribution | |
| 355-5545-1 | In distribution | |
| 410-1059 | In distribution | |
| 381-T080 | In distribution | |
| 10-2014 | In distribution | |
| 353-4585-1 | In distribution | |
| 353-6560-1 | In distribution | |
| 380-9580-S | In distribution | |
| 351-S080 | In distribution | |
| 353-6585-1 | In distribution | |
| 380-6530-F | In distribution | |
| 353-4595-1 | In distribution | |
| 355-7550-1 | In distribution | |
| 383-9560-C | In distribution | |
| 380-9555-F | In distribution | |
| 350-75100-1 | In distribution | |
| 380-5525-F | In distribution | |
| 353-8595-1 | In distribution | |
| 353-1001 | In distribution | |
| 980-33 | In distribution | |
| 355-9535-1 | In distribution | |
| 380-8560-C | In distribution | |
| 383-4570-S | In distribution | |
| 350-7575-1 | In distribution | |
| 380-T070 | In distribution | |
| 353-6565-1 | In distribution | |
| 353-6580-1 | In distribution | |
| 380-10550-S | In distribution | |
| 355-9560-1 | In distribution | |
| 383-6545-S | In distribution | |
| 353-8590-1 | In distribution | |
| 389-1072-3 | In distribution | |
| 350-4575-1 | In distribution | |
| 383-8555-C | In distribution | |
| 383-6550-S | In distribution | |
| 383-10590-C | In distribution | |
| 380-7585-F | In distribution | |
| 353-C065 | In distribution | |
| 355-5530-1 | In distribution | |
| 383-5545-S | In distribution | |
| 380-7525-F | In distribution | |
| 353-5595-1 | In distribution | |
| 381-T150 | In distribution | |
| 350-6550-1 | In distribution | |
| 381-C035 | In distribution | |
| 380-5525-C | In distribution | |
| 380-4570-S | In distribution | |
| 351-C065 | In distribution | |
| 355-7530-1 | In distribution | |
| 383-7560-C | In distribution | |
| 353-S120 | In distribution | |
| 355-7525-1 | In distribution | |
| 980-2003 | In distribution | |
| 380-85105-F | In distribution | |
| 353-9585-1 | In distribution | |
| 380-55105-C | In distribution | |
| 383-8585-C | In distribution | |
| 380-7545-F | In distribution | |
| 380-8540-F | In distribution | |
| 410-6535 | In distribution | |
| 380-9565-S | In distribution | |
| 380-C100 | In distribution | |
| 380-9585-S | In distribution | |
| 350-9595-1 | In distribution | |
| 989-1062-CJ | In distribution | |
| 380-C160 | In distribution | |
| 380-8565-F | In distribution | |
| 355-6560-1 | In distribution | |
| 380-9575-F | In distribution | |
| 381-C050 | In distribution | |
| 353-6530-1 | In distribution | |
| 380-6560-F | In distribution | |
| 380-9525-S | In distribution | |
| 353-7530-1 | In distribution | |
| 380-5575-S | In distribution | |
| 350-8580-1 | In distribution | |
| 350-9590-1 | In distribution | |
| 380-10525-F | In distribution | |
| 380-5595-C | In distribution | |
| 10-2008-30 | In distribution | |
| 380-5570-F | In distribution | |
| 380-9535-F | In distribution | |
| 381-C045 | In distribution | |
| 383-5590-S | In distribution | |
| 350-7525-1 | In distribution | |
| 380-6535-F | In distribution | |
| 383-7570-C | In distribution | |
| 350-5580-1 | In distribution | |
| 389-1015 | In distribution | |
| 350-C070 | In distribution | |
| 380-5585-F | In distribution | |
| 383-8595-C | In distribution | |
| 383-6590-S | In distribution | |
| 355-6575-1 | In distribution | |
| 355-8555-1 | In distribution | |
| 355-9580-1 | In distribution | |
| 350-1001 | In distribution | |
| 383-10575-C | In distribution | |
| 351-C090 | In distribution | |
| 350-1000 | In distribution | |
| 350-6525-1 | In distribution | |
| 353-6570-1 | In distribution | |
| 353-8545-1 | In distribution | |
| 380-C095 | In distribution | |
| 380-T060 | In distribution | |
| 380-7535-S | In distribution | |
| 380-T150 | In distribution | |
| 981-38 | In distribution | |
| 989-1010-65 | In distribution | |
| 389-1024-C | In distribution | |
| 380-4560-S | In distribution | |
| 383-10570-C | In distribution | |
| 383-7530-C | In distribution | |
| 381-C065 | In distribution | |
| 380-7530-F | In distribution | |
| 380-T180 | In distribution | |
| 351-S085 | In distribution | |
| 350-6545-1 | In distribution | |
| 350-1003 | In distribution | |
| 350-C040 | In distribution | |
| 380-10540-F | In distribution | |
| 350-5555-1 | In distribution | |
| 410-1005-50 | In distribution | |
| 353-95100-1 | In distribution | |
| 383-8545-C | In distribution | |
| 389-1072-6 | In distribution | |
| 350-S035 | In distribution | |
| 350-S080 | In distribution | |
| 380-9545-F | In distribution | |
| 380-5595-S | In distribution | |
| 350-55100-1 | In distribution | |
| 380-8565-C | In distribution | |
| 383-6580-C | In distribution | |
| 380-T110 | In distribution | |
| 380-7550-S | In distribution | |
| 355-9575-1 | In distribution | |
| 351-C085 | In distribution | |
| 353-9525-1 | In distribution | |
| 383-6580-S | In distribution | |
| 380-8575-F | In distribution | |
| 383-7535-C | In distribution | |
| 380-4525-C | In distribution | |
| 350-9570-1 | In distribution | |
| 353-8540-1 | In distribution | |
| 380-8530-C | In distribution | |
| 353-8535-1 | In distribution | |
| 380-5590-S | In distribution | |
| 351-C035 | In distribution | |
| 353-S110 | In distribution | |
| 380-4555-S | In distribution | |
| 350-C130 | In distribution | |
| 380-8585-C | In distribution | |
| 383-9595-C | In distribution | |
| 353-6595-1 | In distribution | |
| ZAV-1279-14 | In distribution | |
| 980-38 | In distribution | |
| 353-7590-1 | In distribution | |
| 380-5575-C | In distribution | |
| 355-5595-1 | In distribution | |
| 989-1062-SH | In distribution | |
| 383-55100-S | In distribution | |
| 380-4590-S | In distribution | |
| 380-C130 | In distribution | |
| ZAV-1279-12 | In distribution | |
| 380-7530-C | In distribution | |
| 355-5580-1 | In distribution | |
| 383-5595-S | In distribution | |
| 350-S045 | In distribution | |
| 350-4570-1 | In distribution | |
| 383-4550-S | In distribution | |
| 380-9545-S | In distribution | |
| 380-85100-F | In distribution | |
| 380-10570-S | In distribution | |
| 383-5540-S | In distribution | |
| 353-4550-1 | In distribution | |
| 353-5530-1 | In distribution | |
| 380-6575-F | In distribution | |
| 381-C040 | In distribution | |
| 353-4555-1 | In distribution | |
| 383-9575-C | In distribution | |
| 383-7525-C | In distribution | |
| 380-6595-F | In distribution | |
| 355-8570-1 | In distribution | |
| 380-9535-S | In distribution | |
| 355-85100-1 | In distribution | |
| 353-6575-1 | In distribution | |
| 380-7560-S | In distribution | |
| 380-T200 | In distribution | |
| 380-7595-S | In distribution | |
| 350-5590-1 | In distribution | |
| 353-S035 | In distribution | |
| 355-5555-1 | In distribution | |
| 989-1010-45 | In distribution | |
| 381-T200 | In distribution | |
| 380-4535-S | In distribution | |
| 380-4530-S | In distribution | |
| 353-7570-1 | In distribution | |
| 383-7580-C | In distribution | |
| 381-C140 | In distribution | |
| 350-4585-1 | In distribution | |
| 353-5550-1 | In distribution | |
| 10-2008-25 | In distribution | |
| 380-7565-S | In distribution | |
| 353-8570-1 | In distribution | |
| 383-9590-C | In distribution | |
| 380-4595-S | In distribution | |
| 380-9590-S | In distribution | |
| 381-T075 | In distribution | |
| 989-1062-CH | In distribution | |
| 380-4550-C | In distribution | |
| 353-C070 | In distribution | |
| 353-9555-1 | In distribution | |
| 380-7575-C | In distribution | |
| 410-1051 | In distribution | |
| 355-8535-1 | In distribution | |
| 383-6575-C | In distribution | |
| 980-35 | In distribution | |
| 355-5590-1 | In distribution | |
| 353-S085 | In distribution | |
| 353-S045 | In distribution | |
| 389-1072-2 | In distribution | |
| 350-7580-1 | In distribution | |
| 350-6555-1 | In distribution | |
| 351-S095 | In distribution | |
| 383-4595-S | In distribution | |
| 381-T170 | In distribution | |
| 383-6585-C | In distribution | |
| 380-8550-C | In distribution | |
| 350-S100 | In distribution | |
| 380-8545-C | In distribution | |
| 350-9580-1 | In distribution | |
| 380-9590-F | In distribution | |
| 351-C110 | In distribution | |
| 381-C070 | In distribution | |
| 380-8570-F | In distribution | |
| 350-C080 | In distribution | |
| 381-C190 | In distribution | |
| 389-1008-45 | In distribution | |
| 380-8555-S | In distribution | |
| 351-S150 | In distribution | |
| 350-9525-1 | In distribution | |
| 383-65105-S | In distribution | |
| 350-6595-1 | In distribution | |
| 380-6550-C | In distribution | |
| 389-1008-75 | In distribution | |
| 380-9550-F | In distribution | |
| 351-C045 | In distribution | |
| 380-7595-F | In distribution | |
| 380-8585-S | In distribution | |
| 350-C035 | 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.