Zavation Deformity Polyaxial Screw
Fenestrated Cortical-Cancellous Threaded Screw 10.5 x 105
15manufacturers in China registered for this device type
1,427catalogue 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) | K222614 |
| Record published | 2024-10-22 |
| Record revised | 2025-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1011-C-8560-F | In distribution | |
| 1011-C-4525-C | In distribution | |
| 1010-C-5530-S | In distribution | |
| 1010-C-6595-S | In distribution | |
| 1011-S-8530-F | In distribution | |
| 1010-S-4585-C | In distribution | |
| 1010-S-6570-F | In distribution | |
| 1010-S-6530-C | In distribution | |
| 1011-C-4530-S | In distribution | |
| 1011-S-8555-C | In distribution | |
| 1011-C-10590-S | In distribution | |
| 1010-S-6550-C | In distribution | |
| 1011-C-5560-F | In distribution | |
| 1011-C-45100-C | In distribution | |
| 1011-C-9555-C | In distribution | |
| 1010-S-6555-F | In distribution | |
| 1011-C-9580-S | In distribution | |
| 1010-S-8545-F | In distribution | |
| 1011-C-5580-F | In distribution | |
| 1011-S-9525-C | In distribution | |
| 1011-C-7535-C | In distribution | |
| 1011-S-5535-C | In distribution | |
| 1011-S-4555-C | In distribution | |
| 1011-C-7535-F | In distribution | |
| 1010-S-7555-C | In distribution | |
| 1010-C-8545-F | In distribution | |
| 1011-C-5550-F | In distribution | |
| 1010-C-10535-C | In distribution | |
| 1010-C-105105-F | In distribution | |
| 1010-C-9565-F | In distribution | |
| 1011-S-10590-F | In distribution | |
| 1010-C-45105-S | In distribution | |
| 1011-S-6560-C | In distribution | |
| 1010-S-10590-F | In distribution | |
| 1011-S-105105-C | In distribution | |
| 1010-C-65110-S | In distribution | |
| 1010-S-7580-C | In distribution | |
| 1010-C-4580-C | In distribution | |
| 1011-C-9540-C | In distribution | |
| 1010-S-4580-S | In distribution | |
| 1010-C-4580-S | In distribution | |
| 1011-C-8525-C | In distribution | |
| 1010-S-10585-F | In distribution | |
| 1010-C-5590-S | In distribution | |
| 1011-C-6585-F | In distribution | |
| 1010-C-8590-S | In distribution | |
| 1010-C-6530-S | In distribution | |
| 1010-S-9590-C | In distribution | |
| 1010-C-7585-S | In distribution | |
| 1011-C-8545-C | In distribution | |
| 1011-C-6540-S | In distribution | |
| 1010-S-7545-C | In distribution | |
| 1010-S-8525-F | In distribution | |
| 1010-C-5575-S | In distribution | |
| 1011-S-10560-C | In distribution | |
| 1011-S-9555-F | In distribution | |
| 1011-C-9540-S | In distribution | |
| 1010-C-9580-C | In distribution | |
| 1010-S-4550-C | In distribution | |
| 1011-C-8555-F | In distribution | |
| 1010-S-4580-C | In distribution | |
| 1010-S-7535-F | In distribution | |
| 1011-C-5580-C | In distribution | |
| 1011-C-6595-C | In distribution | |
| 1010-C-10550-C | In distribution | |
| 1010-S-5535-C | In distribution | |
| 1010-C-7565-F | In distribution | |
| 1010-S-10550-C | In distribution | |
| 1010-C-55100-F | In distribution | |
| 1010-S-8590-C | In distribution | |
| 1011-S-8535-F | In distribution | |
| 1010-S-5550-C | In distribution | |
| 1010-C-85105-C | In distribution | |
| 1011-C-85110-F | In distribution | |
| 1010-S-45100-C | In distribution | |
| 1010-C-8550-S | In distribution | |
| 1011-C-10550-S | In distribution | |
| 1010-S-6595-F | In distribution | |
| 1010-S-55105-F | In distribution | |
| 1011-C-4595-S | In distribution | |
| 1011-C-7560-S | In distribution | |
| 1011-S-7570-F | In distribution | |
| 1011-S-7535-F | In distribution | |
| 1010-C-5525-C | In distribution | |
| 1011-C-6575-F | In distribution | |
| 1011-S-10565-C | In distribution | |
| 1010-C-10525-C | In distribution | |
| 1011-C-8530-F | In distribution | |
| 1010-C-9555-C | In distribution | |
| 1010-C-85110-F | In distribution | |
| 1010-S-75105-C | In distribution | |
| 1011-C-10555-C | In distribution | |
| 1010-S-8540-C | In distribution | |
| 1010-S-6570-C | In distribution | |
| 1010-C-10580-S | In distribution | |
| 1011-S-7550-F | In distribution | |
| 1011-C-5555-C | In distribution | |
| 1011-C-9545-S | In distribution | |
| 1010-C-55110-C | In distribution | |
| 1011-S-5530-S | In distribution | |
| 1010-C-4550-S | In distribution | |
| 1010-S-5525-F | In distribution | |
| 1011-S-4570-C | In distribution | |
| 1010-S-6570-S | In distribution | |
| 1010-C-85105-S | In distribution | |
| 1011-C-10560-S | In distribution | |
| 1010-C-9560-C | In distribution | |
| 1011-S-9545-F | In distribution | |
| 1010-S-5535-F | In distribution | |
| 1010-C-105105-S | In distribution | |
| 1010-S-5590-S | In distribution | |
| 1010-C-5565-F | In distribution | |
| 1010-S-5545-F | In distribution | |
| 1011-C-8570-S | In distribution | |
| 1011-C-7565-F | In distribution | |
| 1011-S-5555-C | In distribution | |
| 1011-S-10550-C | In distribution | |
| 1010-S-6580-S | In distribution | |
| 1011-C-10530-F | In distribution | |
| 1010-S-5570-C | In distribution | |
| 1010-S-8560-S | In distribution | |
| 1011-C-9575-F | In distribution | |
| 1010-S-8575-F | In distribution | |
| 1011-S-10575-F | In distribution | |
| 1010-C-4590-C | In distribution | |
| 1011-C-105105-S | In distribution | |
| 1010-C-5565-S | In distribution | |
| 1010-C-4585-S | In distribution | |
| 1011-C-5545-C | In distribution | |
| 1010-C-95100-S | In distribution | |
| 1010-C-6565-F | In distribution | |
| 1010-S-7535-S | In distribution | |
| 1010-S-5585-S | In distribution | |
| 1010-S-10550-F | In distribution | |
| 1011-S-10565-F | In distribution | |
| 1011-C-6530-F | In distribution | |
| 1011-C-6565-C | In distribution | |
| 1011-S-10570-F | In distribution | |
| 1010-C-4565-S | In distribution | |
| 1011-C-8590-S | In distribution | |
| 1011-S-95105-F | In distribution | |
| 1010-S-7540-C | In distribution | |
| 1010-S-10550-S | In distribution | |
| 1011-S-4560-C | In distribution | |
| 1010-C-7575-C | In distribution | |
| 1010-S-9570-C | In distribution | |
| 1011-C-4555-C | In distribution | |
| 1011-C-9550-C | In distribution | |
| 1010-S-9565-S | In distribution | |
| 1011-C-10545-F | In distribution | |
| 1010-C-8530-S | In distribution | |
| 1010-C-4585-C | In distribution | |
| 1010-C-5595-C | In distribution | |
| 1010-C-4560-S | In distribution | |
| 1010-C-85100-C | In distribution | |
| 1011-C-8595-S | In distribution | |
| 1010-C-10530-C | In distribution | |
| 1011-C-10525-S | In distribution | |
| 1011-C-6550-S | In distribution | |
| 1010-C-6550-F | In distribution | |
| 1010-S-4545-C | In distribution | |
| 1010-S-8575-S | In distribution | |
| 1011-C-9590-F | In distribution | |
| 1011-C-7530-S | In distribution | |
| 1011-C-5545-S | In distribution | |
| 1011-S-4580-C | In distribution | |
| 1011-C-9535-C | In distribution | |
| 1010-C-8555-F | In distribution | |
| 1011-S-6585-C | In distribution | |
| 1011-S-9540-F | In distribution | |
| 1011-C-8540-F | In distribution | |
| 1010-S-85105-C | In distribution | |
| 1010-S-9565-C | In distribution | |
| 1011-S-8555-F | In distribution | |
| 1011-C-6540-C | In distribution | |
| 1010-S-95100-F | In distribution | |
| 1011-C-7595-C | In distribution | |
| 1010-S-7580-S | In distribution | |
| 1010-C-7555-C | In distribution | |
| 1010-S-7590-F | In distribution | |
| 1011-S-6595-C | In distribution | |
| 1010-S-8555-S | In distribution | |
| 1011-C-4590-S | In distribution | |
| 1010-S-55110-C | In distribution | |
| 1010-C-95110-S | In distribution | |
| 1010-C-8570-S | In distribution | |
| 1010-S-5560-C | In distribution | |
| 1010-S-8585-S | In distribution | |
| 1011-C-5575-C | In distribution | |
| 1011-C-8560-C | In distribution | |
| 1010-C-10570-F | In distribution | |
| 1010-S-8550-S | In distribution | |
| 1011-C-5540-C | In distribution | |
| 1010-S-8595-C | In distribution | |
| 1011-S-5585-C | In distribution | |
| 1011-C-85110-C | In distribution | |
| 1010-S-8565-C | In distribution | |
| 1011-C-10575-C | In distribution | |
| 1010-C-75110-F | In distribution | |
| 1010-S-5570-F | In distribution | |
| 1011-S-10580-F | In distribution | |
| 1011-C-105110-S | In distribution | |
| 1011-S-10575-C | In distribution | |
| 1010-C-9550-S | In distribution | |
| 1010-C-10530-F | In distribution | |
| 1010-C-8565-C | In distribution | |
| 1010-C-7545-C | In distribution | |
| 1010-S-9525-F | In distribution | |
| 1010-C-8530-F | In distribution | |
| 1011-S-4550-C | In distribution | |
| 1011-C-4565-S | In distribution | |
| 1010-C-105100-S | In distribution | |
| 1011-S-95105-C | In distribution | |
| 1010-C-8560-C | In distribution | |
| 1010-C-10545-F | In distribution | |
| 1011-C-10575-F | In distribution | |
| 1011-S-8540-F | In distribution | |
| 1010-C-9535-F | In distribution | |
| 1011-C-8575-C | In distribution | |
| 1011-S-4540-C | In distribution | |
| 1011-C-45105-S | In distribution | |
| 1010-C-85110-S | In distribution | |
| 1010-S-45105-S | In distribution | |
| 1010-C-6535-S | In distribution | |
| 1010-S-95100-C | In distribution | |
| 1010-C-65105-S | In distribution | |
| 1010-S-6530-S | In distribution | |
| 1011-S-4595-S | In distribution | |
| 1010-S-95110-S | In distribution | |
| 1011-S-105105-F | In distribution | |
| 1010-C-5530-C | In distribution | |
| 1010-S-8545-S | In distribution | |
| 1010-S-7540-F | In distribution | |
| 1010-S-9560-S | In distribution | |
| 1010-S-8550-F | In distribution | |
| 1011-S-10595-F | In distribution | |
| 1010-S-4590-S | In distribution | |
| 1011-C-5570-C | In distribution | |
| 1011-S-9575-F | In distribution | |
| 1010-C-5590-C | In distribution | |
| 1010-S-9580-F | In distribution | |
| 1011-C-75105-F | In distribution | |
| 1010-S-10545-S | In distribution | |
| 1011-C-5530-S | In distribution | |
| 1010-C-8540-F | In distribution | |
| 1011-C-7575-S | In distribution | |
| 1010-C-7535-S | In distribution | |
| 1010-C-6540-S | In distribution | |
| 1011-C-8540-S | In distribution | |
| 1010-S-6555-C | 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.