Cypher MIS Screw System

56 catalogue numbers from 14-571309C, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.

Registry build 21.09.26
13manufacturers in China registered for this device type
56catalogue 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 MNI
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

Regulatory record for Cypher MIS Screw System
Listed by Biomet Spine, United States
FDA product code MNI
Device type Orthosis, Spinal Pedicle Fixation
Device class Class 2
Regulation 21 CFR 888.3070
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

Catalogue Numbers

Catalogue numbers for Cypher MIS Screw System
Catalogue number Size Status
14-571309C 5.5 TI 5.5X145MM CANN TRANS In distribution
14-571027 200MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571208C 5.5 TI 5.0X140MM CANN TRANS In distribution
14-571840C 5.5 TI 10.5X40MM CANN TRANS In distribution
14-571703C 5.5 TI 9.5X115MM CANN TRANS In distribution
14-571602C 5.5 TI 8.5X110MM CANN TRANS In distribution
14-571003 30MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571807C 5.5 TI 10.5X135MM CANN TRANS In distribution
14-571915 150MM CURVED ROD, 5.5 MIS TI In distribution
14-571708C 5.5 TI 9.5X140MM CANN TRANS In distribution
14-571020 130MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571325C 5.5 TI 5.5X25MM CANN TRANS In distribution
14-571508C 5.5 TI 7.5X140MM CANN TRANS In distribution
14-571045 380MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571595C 5.5 TI 7.5X95MM CANN TRANS In distribution
14-571030 230MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571809C 5.5 TI 10.5X145MM CANN TRANS In distribution
14-571306C 5.5 TI 5.5X130MM CANN TRANS In distribution
14-571495C 5.5 TI 6.5X95MM CANN TRANS In distribution
14-571245C 5.5 TI 5.0X45MM CANN TRANS In distribution
14-571808C 5.5 TI 10.5X140MM CANN TRANS In distribution
14-571435C 5.5 TI 6.5X35MM CANN TRANS In distribution
14-571043 360MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571265C 5.5 TI 5.0X65MM CANN TRANS In distribution
14-571805C 5.5 TI 10.5X125MM CANN TRANS In distribution
14-571845C 5.5 TI 10.5X45MM CANN TRANS In distribution
14-571048 410MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571603C 5.5 TI 8.5X115MM CANN TRANS In distribution
14-571705C 5.5 TI 9.5X125MM CANN TRANS In distribution
14-571810C 5.5 TI 10.5X150MM CANN TRANS In distribution
14-571704C 5.5 TI 9.5X120MM CANN TRANS In distribution
14-571685C 5.5 TI 8.5X85MM CANN TRANS In distribution
14-571875C 5.5 TI 10.5X75MM CANN TRANS In distribution
14-571860C 5.5 TI 10.5X60MM CANN TRANS In distribution
14-571785C 5.5 TI 9.5X85MM CANN TRANS In distribution
14-571207C 5.5 TI 5.0X135MM CANN TRANS In distribution
14-571740C 5.5 TI 9.5X40MM CANN TRANS In distribution
14-571320C 5.5 TI 5.5X20MM CANN TRANS In distribution
14-571014 85MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571021 140MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571235C 5.5 TI 5.0X35MM CANN TRANS In distribution
14-571403C 5.5 TI 6.5X115MM CANN TRANS In distribution
14-500500 5.5 MIS HF TI SET SCREW In distribution
14-571710C 5.5 TI 9.5X150MM CANN TRANS In distribution
14-571985 85MM CURVED ROD, 5.5 MIS TI In distribution
14-571502C 5.5 TI 7.5X110MM CANN TRANS In distribution
14-571408C 5.5 TI 6.5X140MM CANN TRANS In distribution
14-571405C 5.5 TI 6.5X125MM CANN TRANS In distribution
14-571540C 5.5 TI 7.5X40MM CANN TRANS In distribution
14-571706C 5.5 TI 9.5X130MM CANN TRANS In distribution
14-571380C 5.5 TI 5.5X80MM CANN TRANS In distribution
14-571016 95MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571506C 5.5 TI 7.5X130MM CANN TRANS In distribution
14-571545C 5.5 TI 7.5X45MM CANN TRANS In distribution
14-571034 270MM STRAIGHT ROD, 5.5 MIS TI In distribution
14-571599C 5.5 TI 7.5X100MM CANN TRANS 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. 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.

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