Cypher™ MIS System
169 catalogue numbers from 2000-3745J, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
169catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal 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 |
|---|---|---|
| 2000-3745J | 9.5X45MM CANN MAS DBLD SCREW | In distribution |
| 14-571806C | 5.5 TI 10.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3702J | 9.5X110MM CANN MAS DBLD SCREW | In distribution |
| 14-571895C | 5.5 TI 10.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3606J | 8.5X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571008 | 55MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571027 | 200MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571507 | 5.5 TI 7.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3625J | 8.5X25MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3285J | 5.0X85MM CANN MAS DBLD SCREW | In distribution |
| 2000-3409J | 6.5X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571225C | 5.5 TI 5.0X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3845J | 10.5X45MM CANN MAS DBLD SCREW | In distribution |
| 14-571460C | 5.5 TI 6.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571015 | 90MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3725J | 9.5X25MM CANN MAS DBLD SCREW | In distribution |
| 2000-3470J | 6.5X70MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3404J | 6.5X120MM CANN MAS DBLD SCREW | In distribution |
| 2000-3809J | 10.5X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571020 | 130MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571701C | 5.5 TI 9.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571485 | 5.5 TI 6.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571021 | 140MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3540J | 7.5X40MM CANN MAS DBLD SCREW | In distribution |
| 2000-3610J | 8.5X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3404J | 6.5X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3575J | 7.5X75MM CANN MAS DBLD SCREW | In distribution |
| 2000-3670J | 8.5X70MM CANN MAS DBLD SCREW | In distribution |
| 14-571005 | 40MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3445J | 6.5X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3604J | 8.5X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3603J | 8.5X115MM CANN MAS DBLD SCREW | In distribution |
| 2000-3406J | 6.5X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3375J | 5.5X75MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571775 | 5.5 TI 9.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3695J | 8.5X95MM CANN MAS DBLD SCREW | In distribution |
| 14-571805C | 5.5 TI 10.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571407C | 5.5 TI 6.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3850J | 10.5X50MM CANN MAS DBLD SCREW | In distribution |
| 2000-3601J | 8.5X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571785 | 5.5 TI 9.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3299J | 5.0X100MM CANN MAS DBLD SCREW | In distribution |
| 2000-3605J | 8.5X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571630C | 5.5 TI 8.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571505 | 5.5 TI 7.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3209J | 5.0X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571508C | 5.5 TI 7.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571599 | 5.5 TI 7.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3760J | 9.5X60MM CANN MAS DBLD SCREW | In distribution |
| 2000-3306J | 5.5X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571375 | 5.5 TI 5.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571565C | 5.5 TI 7.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571807 | 5.5 TI 10.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571350 | 5.5 TI 5.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571202C | 5.5 TI 5.0X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571402 | 5.5 TI 6.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571235C | 5.5 TI 5.0X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3509J | 7.5X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3201J | 5.0X105MM CANN MAS DBLD SCREW | In distribution |
| 2000-3620J | 8.5X20MM CANN MAS DBLD SCREW | In distribution |
| 2000-3780J | 9.5X80MM CANN MAS DBLD SCREW | In distribution |
| 14-571985 | 85MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3460J | 6.5X60MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3405J | 6.5X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571340C | 5.5 TI 5.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571545C | 5.5 TI 7.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571803C | 5.5 TI 10.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3709J | 9.5X145MM CANN MAS DBLD SCREW | In distribution |
| 2000-3345J | 5.5X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571395C | 5.5 TI 5.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571530 | 5.5 TI 7.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3585J | 7.5X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3408J | 6.5X140MM CANN MAS DBLD SCREW | In distribution |
| 14-571660 | 5.5 TI 8.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571203 | 5.5 TI 5.0X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3709J | 9.5X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3445J | 6.5X45MM CANN MAS DBLD SCREW | In distribution |
| 14-571760 | 5.5 TI 9.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571051 | 440MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571455 | 5.5 TI 6.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571024 | 170MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571540 | 5.5 TI 7.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571206C | 5.5 TI 5.0X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3430J | 6.5X30MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3899J | 10.5X100MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3895J | 10.5X95MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571535 | 5.5 TI 7.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571260 | 5.5 TI 5.0X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571240 | 5.5 TI 5.0X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3801J | 10.5X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3340J | 5.5X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571295 | 5.5 TI 5.0X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571460 | 5.5 TI 6.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3201J | 5.0X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3401J | 6.5X105MM CANN MAS DBLD SCREW | In distribution |
| 14-571501 | 5.5 TI 7.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3805J | 10.5X125MM CANN MAS DBLD SCREW | In distribution |
| 14-571610 | 5.5 TI 8.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3290J | 5.0X90MM CANN MAS DBLD SCREW | In distribution |
| 14-571775C | 5.5 TI 9.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571385C | 5.5 TI 5.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571765C | 5.5 TI 9.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571625 | 5.5 TI 8.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571450 | 5.5 TI 6.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3255J | 5.0X55MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571795 | 5.5 TI 9.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3209J | 5.0X145MM CANN MAS DBLD SCREW | In distribution |
| 14-571285 | 5.5 TI 5.0X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571435C | 5.5 TI 6.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3202J | 5.0X110MM CANN MAS DBLD SCREW | In distribution |
| 2000-3703J | 9.5X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571408C | 5.5 TI 6.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571030 | 230MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571401 | 5.5 TI 6.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3399J | 5.5X100MM CANN MAS DBLD SCREW | In distribution |
| 14-571804C | 5.5 TI 10.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3403J | 6.5X115MM CANN MAS DBLD SCREW | In distribution |
| 14-571480C | 5.5 TI 6.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3795J | 9.5X95MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3520J | 7.5X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571780 | 5.5 TI 9.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571019 | 120MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3775J | 9.5X75MM CANN MAS DBLD SCREW | In distribution |
| 2000-3304J | 5.5X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3801J | 10.5X105MM CANN MAS DBLD SCREW | In distribution |
| 2000-3495J | 6.5X95MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3225J | 5.0X25MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571640 | 5.5 TI 8.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571022 | 150MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571645 | 5.5 TI 8.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3203J | 5.0X115MM CANN MAS DBLD SCREW | In distribution |
| 14-571799 | 5.5 TI 9.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571585 | 5.5 TI 7.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3545J | 7.5X45MM CANN MAS DBLD SCREW | In distribution |
| 14-571770 | 5.5 TI 9.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571595C | 5.5 TI 7.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3560J | 7.5X60MM CANN MAS DBLD SCREW | In distribution |
| 2000-3480J | 6.5X80MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571803 | 5.5 TI 10.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571995 | 95MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3506J | 7.5X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3630J | 8.5X30MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3295J | 5.0X95MM CANN MAS DBLD SCREW | In distribution |
| 14-571801C | 5.5 TI 10.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3280J | 5.0X80MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3550J | 7.5X50MM CANN MAS DBLD SCREW | In distribution |
| 14-571945 | 45MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571207C | 5.5 TI 5.0X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3590J | 7.5X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3275J | 5.0X75MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3205J | 5.0X125MM CANN MAS DBLD SCREW | In distribution |
| 14-571208 | 5.5 TI 5.0X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571830 | 5.5 TI 10.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3880J | 10.5X80MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571835 | 5.5 TI 10.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3208J | 5.0X140MM CANN MAS DBLD SCREW | In distribution |
| 14-571745C | 5.5 TI 9.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3550J | 7.5X50MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571310C | 5.5 TI 5.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571406 | 5.5 TI 6.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571325 | 5.5 TI 5.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3530J | 7.5X30MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3602J | 8.5X110MM CANN MAS DBLD SCREW | In distribution |
| 14-571301C | 5.5 TI 5.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571602C | 5.5 TI 8.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3601J | 8.5X105MM CANN MAS DBLD SCREW | In distribution |
| 2000-3660J | 8.5X60MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3299J | 5.0X100MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3525J | 7.5X25MM CANN MAS DBLD SCREW | In distribution |
Same 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.