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.
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 | 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
| 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 |
|---|---|---|
| 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
| 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.