Cypher™ MIS System
157 catalogue numbers from 2000-3245J, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
157catalogue 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 | 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 | 2020-09-30 |
| 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 |
|---|---|---|
| 2000-3245J | 5.0X45MM CANN MAS DBLD SCREW | In distribution |
| 14-571308C | 5.5 TI 5.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3504J | 7.5X120MM CANN MAS DBLD SCREW | In distribution |
| 14-571603 | 5.5 TI 8.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571790 | 5.5 TI 9.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3895J | 10.5X95MM CANN MAS DBLD SCREW | In distribution |
| 14-571305C | 5.5 TI 5.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571302 | 5.5 TI 5.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571305 | 5.5 TI 5.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3750J | 9.5X50MM CANN MAS DBLD SCREW | In distribution |
| 14-571506C | 5.5 TI 7.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3390J | 5.5X90MM CANN MAS DBLD SCREW | In distribution |
| 14-571809C | 5.5 TI 10.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3701J | 9.5X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3455J | 6.5X55MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3440J | 6.5X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3606J | 8.5X130MM CANN MAS DBLD SCREW | In distribution |
| 2000-3490J | 6.5X90MM CANN MAS DBLD SCREW | In distribution |
| 2000-3770J | 9.5X70MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3565J | 7.5X65MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571930 | 30MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3560J | 7.5X60MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571465 | 5.5 TI 6.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3860J | 10.5X60MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571004 | 35MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571606C | 5.5 TI 8.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571605C | 5.5 TI 8.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3810J | 10.5X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571601C | 5.5 TI 8.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571890 | 5.5 TI 10.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571445 | 5.5 TI 6.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571609C | 5.5 TI 8.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3470J | 6.5X70MM CANN MAS DBLD SCREW | In distribution |
| 14-571607C | 5.5 TI 8.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571655C | 5.5 TI 8.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571360C | 5.5 TI 5.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571290 | 5.5 TI 5.0X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3509J | 7.5X145MM CANN MAS DBLD SCREW | In distribution |
| 2000-3804J | 10.5X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571033 | 260MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571205C | 5.5 TI 5.0X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571899 | 5.5 TI 10.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571206 | 5.5 TI 5.0X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571620C | 5.5 TI 8.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571465C | 5.5 TI 6.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3665J | 8.5X65MM CANN MAS DBLD SCREW | In distribution |
| 2000-3503J | 7.5X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571035 | 280MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3830J | 10.5X30MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571880 | 5.5 TI 10.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3520J | 7.5X20MM CANN MAS DBLD SCREW | In distribution |
| 2000-3808J | 10.5X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571695C | 5.5 TI 8.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571034 | 270MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571430C | 5.5 TI 6.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571209 | 5.5 TI 5.0X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571808 | 5.5 TI 10.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3240J | 5.0X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571704 | 5.5 TI 9.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3507J | 7.5X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3725J | 9.5X25MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571420C | 5.5 TI 6.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571023 | 160MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3345J | 5.5X45MM CANN MAS DBLD SCREW | In distribution |
| 14-571410C | 5.5 TI 6.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571470C | 5.5 TI 6.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571635C | 5.5 TI 8.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571840C | 5.5 TI 10.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3204J | 5.0X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571799C | 5.5 TI 9.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3885J | 10.5X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571450C | 5.5 TI 6.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571875 | 5.5 TI 10.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3402J | 6.5X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571690C | 5.5 TI 8.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3508J | 7.5X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3535J | 7.5X35MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571003 | 30MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571295C | 5.5 TI 5.0X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571601 | 5.5 TI 8.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3803J | 10.5X115MM CANN MAS DBLD SCREW | In distribution |
| 2000-3899J | 10.5X100MM CANN MAS DBLD SCREW | In distribution |
| 14-571802C | 5.5 TI 10.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571590C | 5.5 TI 7.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571499 | 5.5 TI 6.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571520C | 5.5 TI 7.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3305J | 5.5X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571303C | 5.5 TI 5.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571650 | 5.5 TI 8.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3707J | 9.5X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3706J | 9.5X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3403J | 6.5X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3350J | 5.5X50MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571503C | 5.5 TI 7.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571706 | 5.5 TI 9.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3655J | 8.5X55MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3820J | 10.5X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3203J | 5.0X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571565 | 5.5 TI 7.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3390J | 5.5X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3635J | 8.5X35MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571707C | 5.5 TI 9.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571630 | 5.5 TI 8.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571240C | 5.5 TI 5.0X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3755J | 9.5X55MM CANN MAS DBLD SCREW | In distribution |
| 2000-3270J | 5.0X70MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571865C | 5.5 TI 10.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3506J | 7.5X130MM CANN MAS DBLD SCREW | In distribution |
| 14-571290C | 5.5 TI 5.0X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571560C | 5.5 TI 7.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3690J | 8.5X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3809J | 10.5X145MM CANN MAS DBLD SCREW | In distribution |
| 14-571245C | 5.5 TI 5.0X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571855C | 5.5 TI 10.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571670 | 5.5 TI 8.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571320 | 5.5 TI 5.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3255J | 5.0X55MM CANN MAS DBLD SCREW | In distribution |
| 14-571509C | 5.5 TI 7.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571408 | 5.5 TI 6.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571057 | 500MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571502 | 5.5 TI 7.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3730J | 9.5X30MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3307J | 5.5X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571250C | 5.5 TI 5.0X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571685C | 5.5 TI 8.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3545J | 7.5X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3320J | 5.5X20MM CANN MAS DBLD SCREW | In distribution |
| 14-571808C | 5.5 TI 10.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3435J | 6.5X35MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571029 | 220MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3465J | 6.5X65MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571708C | 5.5 TI 9.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3650J | 8.5X50MM CANN MAS DBLD SCREW | In distribution |
| 14-571840 | 5.5 TI 10.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571870 | 5.5 TI 10.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571810 | 5.5 TI 10.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571970 | 70MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3406J | 6.5X130MM CANN MAS DBLD SCREW | In distribution |
| 2000-3425J | 6.5X25MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3220J | 5.0X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571703 | 5.5 TI 9.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571335 | 5.5 TI 5.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571006 | 45MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571010 | 65MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571645C | 5.5 TI 8.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571820C | 5.5 TI 10.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3206J | 5.0X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3770J | 9.5X70MM CANN MAS DBLD SCREW | In distribution |
| 2000-3701J | 9.5X105MM CANN MAS DBLD SCREW | In distribution |
| 14-571710 | 5.5 TI 9.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571038 | 310MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3425J | 6.5X25MM CANN MAS DBLD SCREW | In distribution |
| 14-571435 | 5.5 TI 6.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571260C | 5.5 TI 5.0X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571012 | 75MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3307J | 5.5X135MM CANN MAS DBLD SCREW | In distribution |
| 14-571032 | 250MM STRAIGHT ROD, 5.5 MIS TI | 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.