Starfire™ Pedicle Screw System

STARFIRE,SCREW,POLYAXIAL,CANN,7.5X110

Registry build 21.09.26
13manufacturers in China registered for this device type
135catalogue 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.

Chinese manufacturers registered for FDA product code MNH
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, Spondylolisthesis Spinal Fixation

Record

Regulatory record for Starfire™ Pedicle Screw System
Listed by Choice Spine, LP
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal 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

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 numbers for Starfire™ Pedicle Screw System
Catalogue number Size Status
ET50-6025 Outer Diameter 6 mm In distribution
ET50-5525 Length 25 mm In distribution
ET30-5050 Outer Diameter 5 mm In distribution
ET10-75110 Outer Diameter 7.5 mm In distribution
ET10-55110 Outer Diameter 5.5 mm In distribution
ET50-8075 Length 75 mm In distribution
ET50-8030 Length 30 mm In distribution
ET30-5555 Length 55 mm In distribution
ET10-6540 Length 40 mm In distribution
ET30-7080 Outer Diameter 7 mm In distribution
ET50-8550 Length 50 mm In distribution
ET50-6525 Length 25 mm In distribution
ET10-5055 Outer Diameter 5 mm In distribution
ET30-8065 Outer Diameter 8 mm In distribution
ET10-45110 Length 110 mm In distribution
ET10-75100 Outer Diameter 7.5 mm In distribution
ET50-7540 Outer Diameter 7.5 mm In distribution
ET30-6555 Outer Diameter 6.5 mm In distribution
ET30-7060 Length 60 mm In distribution
ET30-8530 Outer Diameter 8.5 mm In distribution
ET50-4575 Outer Diameter 4.5 mm In distribution
ET50-8580 Length 80 mm In distribution
ET50-6565 Outer Diameter 6.5 mm In distribution
ET30-5090 Length 90 mm In distribution
ET30-55110 Outer Diameter 5.5 mm In distribution
ET10-7050 Outer Diameter 7 mm In distribution
ET30-8030 Outer Diameter 8 mm In distribution
ET30-6050 Outer Diameter 6 mm In distribution
ET30-8560 Length 60 mm In distribution
ET10-45100 Length 100 mm In distribution
ET10-4525 Outer Diameter 4.5 mm In distribution
ET30-4550 Length 50 mm In distribution
ET30-8070 Outer Diameter 8 mm In distribution
ET50-6080 Length 80 mm In distribution
ET30-75110 Outer Diameter 7.5 mm In distribution
ET30-6090 Outer Diameter 6 mm In distribution
ET50-8565 Outer Diameter 8.5 mm In distribution
ET10-5590 Length 90 mm In distribution
ET20-5074 Length 74 mm In distribution
ET10-8030 Length 30 mm In distribution
ET30-6570 Length 70 mm In distribution
ET10-8550 Length 50 mm In distribution
ET30-8060 Length 60 mm In distribution
ET50-80100 Length 100 mm In distribution
ET30-6535 Length 35 mm In distribution
ET50-4550 Length 50 mm In distribution
ET10-4545 Outer Diameter 4.5 mm In distribution
ET10-6570 Length 70 mm In distribution
ET30-7040 Length 40 mm In distribution
ET10-7025 Outer Diameter 7 mm In distribution
ET50-6090 Outer Diameter 6 mm In distribution
ET10-5580 Length 80 mm In distribution
ET50-6075 Length 75 mm In distribution
ET30-6060 Length 60 mm In distribution
ET30-8025 Length 25 mm In distribution
ET50-8545 Length 45 mm In distribution
ET10-5035 Outer Diameter 5 mm In distribution
ET30-45100 Length 100 mm In distribution
ET30-7545 Length 45 mm In distribution
ET50-4570 Outer Diameter 4.5 mm In distribution
ET30-4545 Outer Diameter 4.5 mm In distribution
ET10-5565 Length 65 mm In distribution
ET30-8555 Outer Diameter 8.5 mm In distribution
ET10-6545 Outer Diameter 6.6 mm In distribution
ET10-70110 Outer Diameter 7 mm In distribution
ET10-6045 Length 45 mm In distribution
ET10-7070 Outer Diameter 7 mm In distribution
ET10-0001 In distribution
ET50-5560 Outer Diameter 5.5 mm In distribution
ET50-8555 Outer Diameter 8.5 mm In distribution
ET50-80110 Length 110 mm In distribution
ET10-8050 Outer Diameter 8 mm In distribution
ET10-6525 Outer Diameter 6.6 mm In distribution
ET50-85110 Length 110 mm In distribution
ET10-7560 Length 60 mm In distribution
ET30-7575 Outer Diameter 7.5 mm In distribution
ET30-75100 Length 100 mm In distribution
ET50-5535 Length 35 mm In distribution
ET10-5075 Outer Diameter 5 mm In distribution
ET50-6040 Outer Diameter 6 mm In distribution
ET30-80100 Outer Diameter 8 mm In distribution
ET50-5060 Length 60 mm In distribution
ET50-4545 Outer Diameter 4.5 mm In distribution
ET30-6030 Outer Diameter 6 mm In distribution
ET30-8580 Length 80 mm In distribution
ET50-7075 Length 75 mm In distribution
ET10-7060 Length 60 mm In distribution
ET50-8565 Length 65 mm In distribution
ET50-8570 Outer Diameter 8.5 mm In distribution
ET10-8040 Outer Diameter 8 mm In distribution
ET50-4590 Length 90 mm In distribution
ET10-6080 Outer Diameter 6 mm In distribution
ET30-4555 Outer Diameter 4.5 mm In distribution
ET30-8045 Outer Diameter 8 mm In distribution
ET30-5565 Outer Diameter 5.5 mm In distribution
ET10-7530 Outer Diameter 7.5 mm In distribution
ET10-60100 Length 100 mm In distribution
ET10-7590 Length 90 mm In distribution
ET30-8570 Length 70 mm In distribution
ET30-6580 Length 80 mm In distribution
ET50-7080 Length 80 mm In distribution
ET30-85100 Length 100 mm In distribution
ET50-6590 Length 90 mm In distribution
ET10-5570 Outer Diameter 5.5 mm In distribution
ET10-7045 Length 45 mm In distribution
ET30-7540 Outer Diameter 7.5 mm In distribution
ET30-5575 Outer Diameter 5.5 mm In distribution
ET30-7525 Length 25 mm In distribution
ET50-5045 Outer Diameter 5 mm In distribution
ET10-6075 Length 75 mm In distribution
ET30-6075 Length 75 mm In distribution
ET30-6565 Length 65 mm In distribution
ET30-8540 Outer Diameter 8.5 mm In distribution
ET50-6530 Length 30 mm In distribution
ET50-7565 Outer Diameter 7.5 mm In distribution
ET10-8560 Length 60 mm In distribution
ET30-4540 Length 40 mm In distribution
ET30-4530 Outer Diameter 4.5 mm In distribution
ET50-55110 Outer Diameter 5.5 mm In distribution
ET50-7550 Outer Diameter 7.5 mm In distribution
ET50-7030 Outer Diameter 7 mm In distribution
ET30-7570 Outer Diameter 7.5 mm In distribution
ET10-65100 Outer Diameter 6.6 mm In distribution
ET10-4560 Length 60 mm In distribution
ET10-8570 Outer Diameter 8.5 mm In distribution
ET30-8075 Length 75 mm In distribution
ET10-7525 Length 25 mm In distribution
ET10-7035 Length 35 mm In distribution
ET10-8055 Outer Diameter 8 mm In distribution
ET30-7065 Length 65 mm In distribution
ET30-5035 Length 35 mm In distribution
ET50-8530 Length 30 mm In distribution
ET50-5570 Length 70 mm In distribution
ET50-8575 Outer Diameter 8.5 mm In distribution
ET10-5070 Length 70 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,144
Anax™ 5.5 Spinal System CG MedTech Co., Ltd. 2,177
ReLine Nuvasive, Inc. 2,010
Creo Globus Medical, Inc. 1,619
Perfix™ Spinal System CG MedTech Co., Ltd. 1,476
Apex Spine System Spinecraft LLC 1,193
Olympic Astura Medical 1,173
Arsenal Alphatec Spine, Inc. 1,001
Revere Globus Medical, Inc. 997
Astra Spine System Spinecraft LLC 798
Apex-DL Spine System Spinecraft LLC 735
Zenius Spinal System Medyssey Co., Ltd. 712

Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer