Starfire™ Pedicle Screw System
STARFIRE,SCREW,POLY,REDUCTION,7.0X110
15manufacturers in China registered for this device type
164catalogue 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) | K102204 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (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 |
| Sizes | Length 25 to 110 mm; outer diameter 4.5 to 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ET30-6560 | Outer Diameter 6.5 mm | In distribution |
| ET30-7025 | Outer Diameter 7 mm | In distribution |
| ET30-8545 | Length 45 mm | In distribution |
| ET10-4530 | Length 30 mm | In distribution |
| ET50-6560 | Length 60 mm | In distribution |
| ET50-5090 | Outer Diameter 5 mm | In distribution |
| ET50-7045 | Length 45 mm | In distribution |
| ET50-8055 | Outer Diameter 8 mm | In distribution |
| ET30-5040 | Length 40 mm | In distribution |
| ET50-70110 | Outer Diameter 7 mm | In distribution |
| ET10-8525 | Outer Diameter 8.5 mm | In distribution |
| ET50-85100 | Length 100 mm | In distribution |
| ET10-8080 | Outer Diameter 8 mm | In distribution |
| ET50-7035 | Length 35 mm | In distribution |
| ET10-7080 | Outer Diameter 7 mm | In distribution |
| ET50-8535 | Length 35 mm | In distribution |
| ET10-6565 | Length 65 mm | In distribution |
| ET30-7055 | Length 55 mm | In distribution |
| ET30-4575 | Length 75 mm | In distribution |
| ET10-4565 | Length 65 mm | In distribution |
| ET10-4575 | Length 75 mm | In distribution |
| ET10-5560 | Length 60 mm | In distribution |
| ET10-6070 | Length 70 mm | In distribution |
| ET50-75110 | Length 110 mm | In distribution |
| ET50-4555 | Outer Diameter 4.5 mm | In distribution |
| ET30-7560 | Outer Diameter 7.5 mm | In distribution |
| ET30-5560 | Outer Diameter 5.5 mm | In distribution |
| ET50-6060 | Length 60 mm | In distribution |
| ET30-6525 | Outer Diameter 6.5 mm | In distribution |
| ET10-6060 | Outer Diameter 6 mm | In distribution |
| ET10-8070 | Length 70 mm | In distribution |
| ET10-7075 | Length 75 mm | In distribution |
| ET10-80100 | Outer Diameter 8 mm | In distribution |
| ET10-6575 | Outer Diameter 6.6 mm | In distribution |
| ET30-7555 | Length 55 mm | In distribution |
| ET10-5550 | Outer Diameter 5.5 mm | In distribution |
| ET50-8050 | Length 50 mm | In distribution |
| ET30-8525 | Length 25 mm | In distribution |
| ET30-5080 | Outer Diameter 5 mm | In distribution |
| ET30-7045 | Length 45 mm | In distribution |
| ET50-70100 | Outer Diameter 7 mm | In distribution |
| ET30-5540 | Length 40 mm | In distribution |
| ET30-4525 | Length 25 mm | In distribution |
| ET30-7565 | Outer Diameter 7.5 mm | In distribution |
| ET10-60110 | Outer Diameter 6 mm | In distribution |
| ET30-65100 | Length 100 mm | In distribution |
| ET10-8580 | Length 80 mm | In distribution |
| ET10-6065 | Length 65 mm | In distribution |
| ET30-60110 | Length 110 mm | In distribution |
| ET50-7050 | Length 50 mm | In distribution |
| ET50-8525 | Outer Diameter 8.5 mm | In distribution |
| ET30-5590 | Length 90 mm | In distribution |
| ET10-4555 | Outer Diameter 4.5 mm | In distribution |
| ET30-4535 | Outer Diameter 4.5 mm | In distribution |
| ET10-8575 | Outer Diameter 8.5 mm | In distribution |
| ET10-85100 | Length 100 mm | In distribution |
| ET30-6540 | Length 40 mm | In distribution |
| ET10-5065 | Length 65 mm | In distribution |
| ET50-55100 | Length 100 mm | In distribution |
| ET50-5530 | Outer Diameter 5.5 mm | In distribution |
| ET30-5545 | Outer Diameter 5.5 mm | In distribution |
| ET30-6045 | Length 45 mm | In distribution |
| ET10-7550 | Outer Diameter 7.5 mm | In distribution |
| ET50-5545 | Outer Diameter 5.5 mm | In distribution |
| ET10-80110 | Outer Diameter 8 mm | In distribution |
| ET30-7580 | Length 80 mm | In distribution |
| ET50-50100 | Length 100 mm | In distribution |
| ET30-4590 | Outer Diameter 4.5 mm | In distribution |
| ET50-7025 | Length 25 mm | In distribution |
| ET10-5540 | Outer Diameter 5.5 mm | In distribution |
| ET10-6590 | Outer Diameter 6.6 mm | In distribution |
| ET10-5050 | Length 50 mm | In distribution |
| ET50-6030 | Outer Diameter 6 mm | In distribution |
| ET50-7530 | Length 30 mm | In distribution |
| ET50-5080 | Outer Diameter 5 mm | In distribution |
| ET50-5555 | Length 55 mm | In distribution |
| ET10-5040 | Length 40 mm | In distribution |
| ET30-6070 | Length 70 mm | In distribution |
| ET50-8040 | Length 40 mm | In distribution |
| ET50-7535 | Length 35 mm | In distribution |
| ET50-50110 | Outer Diameter 5 mm | In distribution |
| ET10-4590 | Outer Diameter 4.5 mm | In distribution |
| ET50-4560 | Length 60 mm | In distribution |
| ET50-5030 | Length 30 mm | In distribution |
| ET10-5525 | Outer Diameter 5.5 mm | In distribution |
| ET30-4565 | Length 65 mm | In distribution |
| ET30-8575 | Outer Diameter 8.5 mm | In distribution |
| ET50-8560 | Length 60 mm | In distribution |
| ET50-5065 | Outer Diameter 5 mm | In distribution |
| ET30-6025 | Length 25 mm | In distribution |
| ET30-6590 | Length 90 mm | In distribution |
| ET10-7565 | Outer Diameter 7.5 mm | In distribution |
| ET50-4530 | Length 30 mm | In distribution |
| ET30-65110 | Outer Diameter 6.5 mm | In distribution |
| ET50-8540 | Outer Diameter 8.5 mm | In distribution |
| ET50-6570 | Length 70 mm | In distribution |
| ET10-8530 | Length 30 mm | In distribution |
| ET50-5550 | Outer Diameter 5.5 mm | In distribution |
| ET30-7590 | Length 90 mm | In distribution |
| ET50-7590 | Outer Diameter 7.5 mm | In distribution |
| ET50-75100 | Outer Diameter 7.5 mm | In distribution |
| ET50-7545 | Outer Diameter 7.5 mm | In distribution |
| ET10-7090 | Outer Diameter 7 mm | In distribution |
| ET50-8065 | Outer Diameter 8 mm | In distribution |
| ET50-7060 | Outer Diameter 7 mm | In distribution |
| ET50-8035 | Outer Diameter 8 mm | In distribution |
| ET30-6065 | Outer Diameter 6 mm | In distribution |
| ET30-5570 | Outer Diameter 5.5 mm | In distribution |
| ET10-8090 | Length 90 mm | In distribution |
| ET30-7070 | Length 70 mm | In distribution |
| ET30-85110 | Length 110 mm | In distribution |
| ET50-7575 | Outer Diameter 7.5 mm | In distribution |
| ET30-7035 | Outer Diameter 7 mm | In distribution |
| ET10-65110 | Outer Diameter 6.6 mm | In distribution |
| ET10-5535 | Outer Diameter 5.5 mm | In distribution |
| ET30-7535 | Outer Diameter 7.5 mm | In distribution |
| ET10-5030 | Outer Diameter 5 mm | In distribution |
| ET30-6575 | Length 75 mm | In distribution |
| ET10-6560 | Length 60 mm | In distribution |
| ET10-7575 | Length 75 mm | In distribution |
| ET50-7560 | Outer Diameter 7.5 mm | In distribution |
| ET10-8035 | Outer Diameter 8 mm | In distribution |
| ET50-7055 | Outer Diameter 7 mm | In distribution |
| ET10-7540 | Outer Diameter 7.5 mm | In distribution |
| ET10-5545 | Length 45 mm | In distribution |
| ET30-6080 | Length 80 mm | In distribution |
| ET50-6045 | Outer Diameter 6 mm | In distribution |
| ET30-4580 | Outer Diameter 4.5 mm | In distribution |
| ET50-6550 | Length 50 mm | In distribution |
| ET50-60110 | Length 110 mm | In distribution |
| ET30-7050 | Length 50 mm | In distribution |
| ET50-5540 | Outer Diameter 5.5 mm | In distribution |
| ET10-5080 | Outer Diameter 5 mm | In distribution |
| ET50-6535 | Length 35 mm | In distribution |
| ET10-4580 | Length 80 mm | In distribution |
| ET50-7555 | Length 55 mm | In distribution |
| ET30-5075 | Length 75 mm | In distribution |
| ET30-55100 | Length 100 mm | In distribution |
| ET50-7040 | Length 40 mm | In distribution |
| ET50-7570 | Length 70 mm | In distribution |
| ET10-6040 | Length 40 mm | In distribution |
| ET10-8565 | Outer Diameter 8.5 mm | In distribution |
| ET20-4054 | Length 54 mm | In distribution |
| ET10-4570 | Outer Diameter 4.5 mm | In distribution |
| ET50-6575 | Outer Diameter 6.5 mm | In distribution |
| ET10-7055 | Outer Diameter 7 mm | In distribution |
| ET10-8065 | Length 65 mm | In distribution |
| ET50-5035 | Length 35 mm | In distribution |
| ET30-5580 | Outer Diameter 5.5 mm | In distribution |
| ET50-8080 | Outer Diameter 8 mm | In distribution |
| ET50-8025 | Length 25 mm | In distribution |
| ET30-5025 | Length 25 mm | In distribution |
| ET10-8545 | Length 45 mm | In distribution |
| ET10-7030 | Length 30 mm | In distribution |
| ET30-5070 | Outer Diameter 5 mm | In distribution |
| ET50-65100 | Outer Diameter 6.5 mm | In distribution |
| ET10-7555 | Length 55 mm | In distribution |
| ET30-8565 | Outer Diameter 8.5 mm | In distribution |
| ET50-7065 | Length 65 mm | In distribution |
| ET10-55100 | Length 100 mm | In distribution |
| ET30-8550 | Length 50 mm | In distribution |
| ET10-6535 | Length 35 mm | In distribution |
| ET10-6035 | Outer Diameter 6 mm | In distribution |
| ET30-6550 | Outer Diameter 6.5 mm | 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
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.