Starfire™ Pedicle Screw System
STARFIRE,SCREW,POLYAXIAL,CANN,5.0X110
13manufacturers in China registered for this device type
116catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Choice Spine, LP |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| 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 |
|---|---|---|
| ET30-8040 | Length 40 mm | In distribution |
| ET10-6580 | Length 80 mm | In distribution |
| ET10-50110 | Length 110 mm | In distribution |
| ET10-5530 | Outer Diameter 5.5 mm | In distribution |
| ET30-8055 | Outer Diameter 8 mm | In distribution |
| ET30-5055 | Outer Diameter 5 mm | In distribution |
| ET30-8050 | Outer Diameter 8 mm | In distribution |
| ET50-8590 | Length 90 mm | In distribution |
| ET30-5535 | Length 35 mm | In distribution |
| ET30-7530 | Outer Diameter 7.5 mm | In distribution |
| ET10-5025 | Length 25 mm | In distribution |
| ET10-6530 | Outer Diameter 6.6 mm | In distribution |
| ET30-5525 | Length 25 mm | In distribution |
| ET30-50110 | Outer Diameter 5 mm | In distribution |
| ET30-8590 | Length 90 mm | In distribution |
| ET30-8535 | Length 35 mm | In distribution |
| ET30-6530 | Outer Diameter 6.5 mm | In distribution |
| ET50-5025 | Outer Diameter 5 mm | In distribution |
| ET10-8045 | Length 45 mm | In distribution |
| ET10-70100 | Length 100 mm | In distribution |
| ET50-5590 | Length 90 mm | In distribution |
| ET10-8540 | Length 40 mm | In distribution |
| ET10-7580 | Outer Diameter 7.5 mm | In distribution |
| ET30-6055 | Outer Diameter 6 mm | In distribution |
| ET50-7580 | Length 80 mm | In distribution |
| ET50-8045 | Length 45 mm | In distribution |
| ET50-5050 | Length 50 mm | In distribution |
| ET10-7545 | Outer Diameter 7.5 mm | In distribution |
| ET10-7535 | Outer Diameter 7.5 mm | In distribution |
| ET50-8060 | Length 60 mm | In distribution |
| ET50-5070 | Outer Diameter 5 mm | In distribution |
| ET50-7525 | Outer Diameter 7.5 mm | In distribution |
| ET20-3442 | Length 42 mm | In distribution |
| ET50-65110 | Length 110 mm | In distribution |
| ET30-50100 | Outer Diameter 5 mm | In distribution |
| ET30-6545 | Length 45 mm | In distribution |
| ET50-6055 | Length 55 mm | In distribution |
| ET30-8590 | Outer Diameter 8.5 mm | In distribution |
| ET30-7550 | Length 50 mm | In distribution |
| ET30-8035 | Length 35 mm | In distribution |
| ET30-4560 | Outer Diameter 4.5 mm | In distribution |
| ET50-6580 | Outer Diameter 6.5 mm | In distribution |
| ET30-4570 | Length 70 mm | In distribution |
| ET50-5575 | Outer Diameter 5.5 mm | In distribution |
| ET10-6555 | Outer Diameter 6.6 mm | In distribution |
| ET50-7090 | Length 90 mm | In distribution |
| ET50-4580 | Outer Diameter 4.5 mm | In distribution |
| ET50-7070 | Length 70 mm | In distribution |
| ET10-8075 | Length 75 mm | In distribution |
| ET50-5580 | Length 80 mm | In distribution |
| ET50-4570 | Outer Diameter 4.5 mm | In distribution |
| ET50-4525 | Length 25 mm | In distribution |
| ET50-6070 | Outer Diameter 6 mm | In distribution |
| ET30-6035 | Outer Diameter 6 mm | In distribution |
| ET30-5030 | Outer Diameter 5 mm | In distribution |
| ET30-8090 | Length 90 mm | In distribution |
| ET50-6540 | Outer Diameter 6.5 mm | In distribution |
| ET30-70100 | Length 100 mm | In distribution |
| ET50-45100 | Length 100 mm | In distribution |
| ET50-7575 | Length 75 mm | In distribution |
| ET50-4565 | Outer Diameter 4.5 mm | In distribution |
| ET50-60100 | Length 100 mm | In distribution |
| ET50-5040 | Length 40 mm | In distribution |
| ET50-4540 | Length 40 mm | In distribution |
| ET50-6050 | Length 50 mm | In distribution |
| ET20-3034 | Length 34 mm | In distribution |
| ET10-5060 | Outer Diameter 5 mm | In distribution |
| ET10-4535 | Length 35 mm | In distribution |
| ET30-7575 | Length 75 mm | In distribution |
| ET50-5565 | Length 65 mm | In distribution |
| ET30-7030 | Length 30 mm | In distribution |
| ET10-4540 | Length 40 mm | In distribution |
| ET10-5575 | Outer Diameter 5.5 mm | In distribution |
| ET30-5065 | Outer Diameter 5 mm | In distribution |
| ET50-6555 | Outer Diameter 6.5 mm | In distribution |
| ET30-7090 | Outer Diameter 7 mm | In distribution |
| ET10-8025 | Outer Diameter 8 mm | In distribution |
| ET10-8060 | Outer Diameter 8 mm | In distribution |
| ET30-6040 | Outer Diameter 6 mm | In distribution |
| ET50-6065 | Outer Diameter 6 mm | In distribution |
| ET10-7570 | Outer Diameter 7.5 mm | In distribution |
| ET30-80110 | Outer Diameter 8 mm | In distribution |
| ET50-5055 | Length 55 mm | In distribution |
| ET10-6055 | Outer Diameter 6 mm | In distribution |
| ET30-5530 | Length 30 mm | In distribution |
| ET10-6050 | Outer Diameter 6 mm | In distribution |
| ET50-8090 | Length 90 mm | In distribution |
| ET30-5550 | Length 50 mm | In distribution |
| ET50-4535 | Length 35 mm | In distribution |
| ET10-7065 | Length 65 mm | In distribution |
| ET30-7075 | Outer Diameter 7 mm | In distribution |
| ET10-4550 | Length 50 mm | In distribution |
| ET10-6025 | Outer Diameter 6 mm | In distribution |
| ET30-45110 | Length 110 mm | In distribution |
| ET10-8555 | Length 55 mm | In distribution |
| ET30-5060 | Length 60 mm | In distribution |
| ET30-5045 | Length 45 mm | In distribution |
| ET10-8590 | Outer Diameter 8.5 mm | In distribution |
| ET50-8070 | Outer Diameter 8 mm | In distribution |
| ET10-8535 | Outer Diameter 8.5 mm | In distribution |
| ET10-6090 | Length 90 mm | In distribution |
| ET10-85110 | Length 110 mm | In distribution |
| ET10-6030 | Outer Diameter 6 mm | In distribution |
| ET10-5045 | Length 45 mm | In distribution |
| ET30-8080 | Length 80 mm | In distribution |
| ET10-50100 | Outer Diameter 5 mm | In distribution |
| ET10-7040 | Outer Diameter 7 mm | In distribution |
| ET50-6545 | Length 45 mm | In distribution |
| ET30-70110 | Length 110 mm | In distribution |
| ET10-5555 | Outer Diameter 5.5 mm | In distribution |
| ET30-60100 | Length 100 mm | In distribution |
| ET10-5090 | Outer Diameter 5 mm | In distribution |
| ET50-5075 | Outer Diameter 5 mm | In distribution |
| ET10-6550 | Outer Diameter 6.6 mm | In distribution |
| ET50-6035 | Outer Diameter 6 mm | In distribution |
| ET50-45110 | Outer Diameter 4.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.