Cypher™ MIS System
134 catalogue numbers from 14-571037, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
134catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2020-06-25 |
| 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 |
|---|---|---|
| 14-571037 | 300MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571665 | 5.5 TI 8.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3325J | 5.5X25MM CANN MAS DBLD SCREW | In distribution |
| 2000-3490J | 6.5X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3230J | 5.0X30MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571220 | 5.5 TI 5.0X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3785J | 9.5X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571845C | 5.5 TI 10.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3740J | 9.5X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3675J | 8.5X75MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3225J | 5.0X25MM CANN MAS DBLD SCREW | In distribution |
| 2000-3302J | 5.5X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571054 | 470MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571355 | 5.5 TI 5.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571401C | 5.5 TI 6.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3485J | 6.5X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3365J | 5.5X65MM CANN MAS DBLD SCREW | In distribution |
| 2000-3702J | 9.5X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3706J | 9.5X130MM CANN MAS DBLD SCREW | In distribution |
| 2000-3810J | 10.5X150MM CANN MAS DBLD SCREW | In distribution |
| 14-571785C | 5.5 TI 9.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3710J | 9.5X150MM CANN MAS DBLD SCREW | In distribution |
| 14-571265 | 5.5 TI 5.0X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3765J | 9.5X65MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571390 | 5.5 TI 5.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571445C | 5.5 TI 6.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571209C | 5.5 TI 5.0X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571765 | 5.5 TI 9.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571410 | 5.5 TI 6.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571056 | 490MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571555C | 5.5 TI 7.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571595 | 5.5 TI 7.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571503 | 5.5 TI 7.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571007 | 50MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3704J | 9.5X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3704J | 9.5X120MM CANN MAS DBLD SCREW | In distribution |
| 2000-3503J | 7.5X115MM CANN MAS DBLD SCREW | In distribution |
| 2000-3707J | 9.5X135MM CANN MAS DBLD SCREW | In distribution |
| 2000-3230J | 5.0X30MM CANN MAS DBLD SCREW | In distribution |
| 14-571710C | 5.5 TI 9.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3795J | 9.5X95MM CANN MAS DBLD SCREW | In distribution |
| 14-571042 | 350MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571709 | 5.5 TI 9.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571014 | 85MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571304C | 5.5 TI 5.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3410J | 6.5X150MM CANN MAS DBLD SCREW | In distribution |
| 14-571048 | 410MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3608J | 8.5X140MM CANN MAS DBLD SCREW | In distribution |
| 2000-3395J | 5.5X95MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3685J | 8.5X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571830C | 5.5 TI 10.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571405C | 5.5 TI 6.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571403C | 5.5 TI 6.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571608C | 5.5 TI 8.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3575J | 7.5X75MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571540C | 5.5 TI 7.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571055 | 480MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571725C | 5.5 TI 9.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3645J | 8.5X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571807C | 5.5 TI 10.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571915 | 150MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571685 | 5.5 TI 8.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3250J | 5.0X50MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571402C | 5.5 TI 6.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571406C | 5.5 TI 6.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571665C | 5.5 TI 8.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571495 | 5.5 TI 6.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571525 | 5.5 TI 7.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571835C | 5.5 TI 10.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571395 | 5.5 TI 5.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3370J | 5.5X70MM CANN MAS DBLD SCREW | In distribution |
| 2000-3455J | 6.5X55MM CANN MAS DBLD SCREW | In distribution |
| 14-571031 | 240MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3220J | 5.0X20MM CANN MAS DBLD SCREW | In distribution |
| 14-571490 | 5.5 TI 6.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571699C | 5.5 TI 8.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571255 | 5.5 TI 5.0X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571304 | 5.5 TI 5.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3502J | 7.5X110MM CANN MAS DBLD SCREW | In distribution |
| 14-571825 | 5.5 TI 10.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571208C | 5.5 TI 5.0X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571375C | 5.5 TI 5.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571885C | 5.5 TI 10.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571911 | 110MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3310J | 5.5X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571409 | 5.5 TI 6.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571750 | 5.5 TI 9.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3825J | 10.5X25MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571870C | 5.5 TI 10.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3850J | 10.5X50MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571404 | 5.5 TI 6.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571390C | 5.5 TI 5.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3803J | 10.5X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3630J | 8.5X30MM CANN MAS DBLD SCREW | In distribution |
| 2000-3465J | 6.5X65MM CANN MAS DBLD SCREW | In distribution |
| 14-571707 | 5.5 TI 9.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571720C | 5.5 TI 9.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571046 | 390MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571306 | 5.5 TI 5.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3607J | 8.5X135MM CANN MAS DBLD SCREW | In distribution |
| 14-571308 | 5.5 TI 5.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-500500 | 5.5 MIS HF TI SET SCREW | In distribution |
| 14-571855 | 5.5 TI 10.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571309C | 5.5 TI 5.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571805 | 5.5 TI 10.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571865 | 5.5 TI 10.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3804J | 10.5X120MM CANN MAS DBLD SCREW | In distribution |
| 2000-3860J | 10.5X60MM CANN MAS DBLD SCREW | In distribution |
| 2000-3609J | 8.5X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3640J | 8.5X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3235J | 5.0X35MM CANN MAS DBLD SCREW | In distribution |
| 14-571495C | 5.5 TI 6.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571420 | 5.5 TI 6.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3303J | 5.5X115MM CANN MAS DBLD SCREW | In distribution |
| 14-571602 | 5.5 TI 8.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3840J | 10.5X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571306C | 5.5 TI 5.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571026 | 190MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571303 | 5.5 TI 5.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571507C | 5.5 TI 7.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3845J | 10.5X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571806 | 5.5 TI 10.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571047 | 400MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571820 | 5.5 TI 10.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571560 | 5.5 TI 7.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3608J | 8.5X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571028 | 210MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571702C | 5.5 TI 9.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571052 | 450MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571735 | 5.5 TI 9.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571699 | 5.5 TI 8.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571703C | 5.5 TI 9.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571455C | 5.5 TI 6.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571399 | 5.5 TI 5.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.