Nido Pedicle Screw System
Connector, Adjustable Parallel Tulips Open-Open, 5.5mm
15manufacturers in China registered for this device type
244catalogue 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 | Kalitec Direct, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K230974 |
| Record published | 2023-10-06 |
| Record revised | 2025-07-14 (version 5) |
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 |
|---|---|---|
| 15-BSC-0530 | In distribution | |
| 15-BCC-9545 | In distribution | |
| 15-BSC-5540 | In distribution | |
| 15-BCC-7515 | In distribution | |
| 15-BCC-8590 | In distribution | |
| 15-BCC-9540 | In distribution | |
| 15-BCC-8585 | In distribution | |
| 15-BSC-9575 | In distribution | |
| 15-BCC-0595 | In distribution | |
| 15-BCC-8505 | In distribution | |
| 15-BCC-9560 | In distribution | |
| 15-BCC-5525 | In distribution | |
| 15-CLA-5130 | In distribution | |
| 15-BCC-7505 | In distribution | |
| 15-BSC-8545 | In distribution | |
| 15-BSC-0545 | In distribution | |
| 15-BSC-4750 | In distribution | |
| 15-BCC-8500 | In distribution | |
| 15-BCC-9530 | In distribution | |
| 15-BCC-6575 | In distribution | |
| 15-BCC-7545 | In distribution | |
| 15-BCC-5565 | In distribution | |
| 15-BCC-9570 | In distribution | |
| 15-BSC-8535 | In distribution | |
| 15-BCC-9525 | In distribution | |
| 15-BCC-0575 | In distribution | |
| 15-BSC-7565 | In distribution | |
| 15-BSC-0575 | In distribution | |
| 15-CTP-4000 | In distribution | |
| 15-BSC-6545 | In distribution | |
| 15-BSC-7575 | In distribution | |
| 15-BCC-5530 | In distribution | |
| 15-BCC-6560 | In distribution | |
| 15-BCC-6510 | In distribution | |
| 15-BSC-0580 | In distribution | |
| 15-BCC-8540 | In distribution | |
| 15-CDA-1000 | In distribution | |
| 15-BSC-8525 | In distribution | |
| 15-BCC-6570 | In distribution | |
| 15-BCC-8595 | In distribution | |
| 15-BSC-5545 | In distribution | |
| 15-BCC-8530 | In distribution | |
| 15-MHP-1200 | In distribution | |
| 15-BSC-9555 | In distribution | |
| 15-BSC-8565 | In distribution | |
| 15-BSC-9550 | In distribution | |
| 15-BSC-9595 | In distribution | |
| 15-BCC-8565 | In distribution | |
| 15-BSC-9525 | In distribution | |
| 15-BSC-9515 | In distribution | |
| 15-BCC-4725 | In distribution | |
| 15-BCC-0515 | In distribution | |
| 15-BSC-8530 | In distribution | |
| 15-BCC-9590 | In distribution | |
| 15-BCC-0510 | In distribution | |
| 15-BSC-0515 | In distribution | |
| 15-BSC-8575 | In distribution | |
| 15-BCC-8545 | In distribution | |
| 15-BCC-5560 | In distribution | |
| 15-BCC-8560 | In distribution | |
| 15-BSC-6540 | In distribution | |
| 15-BCC-0500 | In distribution | |
| 15-BSC-8585 | In distribution | |
| 15-CLA-5110 | In distribution | |
| 15-BCC-5545 | In distribution | |
| 15-CLA-5030 | In distribution | |
| 15-BSC-5565 | In distribution | |
| 15-BSC-8595 | In distribution | |
| 15-CLA-5010 | In distribution | |
| 15-BSC-8500 | In distribution | |
| 15-MLC-0000 | In distribution | |
| 15-CLA-5020 | In distribution | |
| 15-BSC-4730 | In distribution | |
| 15-BCC-7565 | In distribution | |
| 15-BSC-6580 | In distribution | |
| 15-BCC-0525 | In distribution | |
| 15-BCC-8550 | In distribution | |
| 15-BSC-4760 | In distribution | |
| 15-BCC-9535 | In distribution | |
| 15-BSC-0560 | In distribution | |
| 15-BCC-6555 | In distribution | |
| 15-BSC-7515 | In distribution | |
| 15-BCC-0585 | In distribution | |
| 15-BCC-9505 | In distribution | |
| 15-BSC-7570 | In distribution | |
| 15-BSC-6595 | In distribution | |
| 15-BSC-4755 | In distribution | |
| 15-BCC-7550 | In distribution | |
| 15-BSC-9540 | In distribution | |
| 15-BSC-7555 | In distribution | |
| 15-BSC-9560 | In distribution | |
| 15-BSC-8570 | In distribution | |
| 15-BSC-7525 | In distribution | |
| 15-BSC-8555 | In distribution | |
| 15-BCC-9515 | In distribution | |
| 15-BSC-6585 | In distribution | |
| 15-BCC-6540 | In distribution | |
| 15-BSC-6525 | In distribution | |
| 15-BSC-7505 | In distribution | |
| 15-BCC-6580 | In distribution | |
| 15-CDS-0000 | In distribution | |
| 15-BCC-4765 | In distribution | |
| 15-BCC-5540 | In distribution | |
| 15-BSC-0550 | In distribution | |
| 15-BCC-7510 | In distribution | |
| 15-BSC-5535 | In distribution | |
| 15-BSC-6570 | In distribution | |
| 15-BCC-4740 | In distribution | |
| 15-BSC-6530 | In distribution | |
| 15-BSC-8515 | In distribution | |
| 15-BSC-7545 | In distribution | |
| 15-BCC-6530 | In distribution | |
| 15-BCC-0570 | In distribution | |
| 15-BCC-7560 | In distribution | |
| 15-BCC-6505 | In distribution | |
| 15-BCC-8525 | In distribution | |
| 15-BSC-0535 | In distribution | |
| 15-BCC-9565 | In distribution | |
| 15-BCC-7540 | In distribution | |
| 15-BSC-0540 | In distribution | |
| 15-BCC-7580 | In distribution | |
| 15-BSC-8580 | In distribution | |
| 15-BCC-0555 | In distribution | |
| 15-BSC-8560 | In distribution | |
| 15-BCC-8570 | In distribution | |
| 15-BCC-6585 | In distribution | |
| 15-BSC-5555 | In distribution | |
| 15-BCC-7570 | In distribution | |
| 15-BCC-9550 | In distribution | |
| 15-BCC-6515 | In distribution | |
| 15-BSC-0585 | In distribution | |
| 15-BSC-7530 | In distribution | |
| 15-BCC-0565 | In distribution | |
| 15-BSC-7590 | In distribution | |
| 15-BCC-4745 | In distribution | |
| 15-BCC-5555 | In distribution | |
| 15-BCC-6535 | In distribution | |
| 15-BSC-0525 | In distribution | |
| 15-BSC-6575 | In distribution | |
| 15-BSC-4745 | In distribution | |
| 15-BCC-9585 | In distribution | |
| 15-BCC-7575 | In distribution | |
| 15-CTP-3000 | In distribution | |
| 15-BSC-6505 | In distribution | |
| 15-BSC-7535 | In distribution | |
| 15-BSC-9580 | In distribution | |
| 15-BSC-0505 | In distribution | |
| 15-BCC-7555 | In distribution | |
| 15-BSC-0555 | In distribution | |
| 15-BCC-7590 | In distribution | |
| 15-BSC-4740 | In distribution | |
| 15-BSC-5525 | In distribution | |
| 15-BSC-0570 | In distribution | |
| 15-BCC-4750 | In distribution | |
| 15-BSC-4735 | In distribution | |
| 15-CLA-5120 | In distribution | |
| 15-CTP-3100 | In distribution | |
| 15-BCC-9555 | In distribution | |
| 15-BSC-9535 | In distribution | |
| 15-BSC-9585 | In distribution | |
| 15-BSC-9530 | In distribution | |
| 15-BSC-9505 | In distribution | |
| 15-BCC-6525 | In distribution | |
| 15-BSC-0595 | In distribution | |
| 15-BCC-8535 | In distribution | |
| 15-BSC-6500 | In distribution | |
| 15-BSC-4765 | In distribution | |
| 15-BCC-6590 | In distribution | |
| 15-BSC-9590 | In distribution | |
| 15-BCC-8515 | In distribution | |
| 15-BSC-6515 | In distribution | |
| 15-BSC-0590 | In distribution | |
| 15-BSC-7560 | In distribution | |
| 15-BSC-8540 | In distribution | |
| 15-BSC-0510 | In distribution | |
| 15-BSC-8590 | In distribution | |
| 15-BCC-7525 | In distribution | |
| 15-BCC-8580 | In distribution | |
| 15-BCC-6595 | In distribution | |
| 15-BCC-0550 | In distribution | |
| 15-BSC-6510 | In distribution | |
| 15-BCC-0505 | In distribution | |
| 15-BCC-7535 | In distribution | |
| 15-BSC-0500 | In distribution | |
| 15-BCC-0530 | In distribution | |
| 15-BCC-7500 | In distribution | |
| 15-CDP-2200 | In distribution | |
| 15-BSC-6590 | In distribution | |
| 15-BCC-5550 | In distribution | |
| 15-BSC-4725 | In distribution | |
| 15-BSC-7595 | In distribution | |
| 15-BCC-6500 | In distribution | |
| 15-BCC-4730 | In distribution | |
| 15-BSC-5550 | In distribution | |
| 15-BCC-7530 | In distribution | |
| 15-CDP-2100 | In distribution | |
| 15-BCC-9500 | In distribution | |
| 15-BCC-4760 | In distribution | |
| 15-BCC-6565 | In distribution | |
| 15-BSC-5530 | In distribution | |
| 15-BSC-9565 | In distribution | |
| 15-BCC-4755 | In distribution | |
| 15-BSC-0565 | In distribution | |
| 15-BSC-9545 | In distribution | |
| 15-BSC-6560 | In distribution | |
| 15-MHP-1000 | In distribution | |
| 15-BCC-5535 | In distribution | |
| 15-BSC-7510 | In distribution | |
| 15-BSC-7580 | In distribution | |
| 15-BSC-6550 | In distribution | |
| 15-CDP-2000 | In distribution | |
| 15-BCC-8510 | In distribution | |
| 15-BSC-7540 | In distribution | |
| 15-BCC-6545 | In distribution | |
| 15-BSC-7585 | In distribution | |
| 15-BCC-0535 | In distribution | |
| 15-BCC-0540 | In distribution | |
| 15-BCC-9575 | In distribution | |
| 15-BSC-8510 | In distribution | |
| 15-BSC-6565 | In distribution | |
| 15-BCC-0545 | In distribution | |
| 15-BSC-6535 | In distribution | |
| 15-BCC-0590 | In distribution | |
| 15-BCC-8555 | In distribution | |
| 15-BCC-9580 | In distribution | |
| 15-BSC-9510 | In distribution | |
| 15-BCC-6550 | In distribution | |
| 15-BCC-9595 | In distribution | |
| 15-BSC-7500 | In distribution | |
| 15-CDP-2210 | In distribution | |
| 15-BCC-4735 | In distribution | |
| 15-BSC-9570 | In distribution | |
| 15-BCC-0580 | In distribution | |
| 15-BSC-5560 | In distribution | |
| 15-BSC-8505 | In distribution | |
| 15-BCC-8575 | In distribution | |
| 15-BSC-7550 | In distribution | |
| 15-MHE-2000 | In distribution | |
| 15-BCC-9510 | In distribution | |
| 15-BCC-7595 | In distribution | |
| 15-BSC-8550 | In distribution | |
| 15-BCC-0560 | In distribution | |
| 15-BSC-6555 | In distribution | |
| 15-BCC-7585 | 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 |
|---|---|
| K172808 | 2017-10-25 |
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.