Cypher™ MIS System
140 catalogue numbers from 14-571307C, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
140catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 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 |
|---|---|---|
| 14-571307C | 5.5 TI 5.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3807J | 10.5X135MM CANN MAS DBLD SCREW | In distribution |
| 2000-3285J | 5.0X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571309 | 5.5 TI 5.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3408J | 6.5X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571220C | 5.5 TI 5.0X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3499J | 6.5X100MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571660C | 5.5 TI 8.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3435J | 6.5X35MM CANN MAS DBLD SCREW | In distribution |
| 2000-3309J | 5.5X145MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571910 | 100MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571604C | 5.5 TI 8.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3305J | 5.5X125MM CANN MAS DBLD SCREW | In distribution |
| 14-571280 | 5.5 TI 5.0X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3485J | 6.5X85MM CANN MAS DBLD SCREW | In distribution |
| 14-571575C | 5.5 TI 7.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3302J | 5.5X110MM CANN MAS DBLD SCREW | In distribution |
| 14-571695 | 5.5 TI 8.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571205 | 5.5 TI 5.0X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571203C | 5.5 TI 5.0X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3830J | 10.5X30MM CANN MAS DBLD SCREW | In distribution |
| 14-571585C | 5.5 TI 7.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571599C | 5.5 TI 7.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3260J | 5.0X60MM CANN MAS DBLD SCREW | In distribution |
| 2000-3705J | 9.5X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3655J | 8.5X55MM CANN MAS DBLD SCREW | In distribution |
| 2000-3245J | 5.0X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3806J | 10.5X130MM CANN MAS DBLD SCREW | In distribution |
| 14-571680C | 5.5 TI 8.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571399C | 5.5 TI 5.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3802J | 10.5X110MM CANN MAS DBLD SCREW | In distribution |
| 2000-3409J | 6.5X145MM CANN MAS DBLD SCREW | In distribution |
| 2000-3240J | 5.0X40MM CANN MAS DBLD SCREW | In distribution |
| 14-571706C | 5.5 TI 9.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571506 | 5.5 TI 7.5X130MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571350C | 5.5 TI 5.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571225 | 5.5 TI 5.0X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3401J | 6.5X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3625J | 8.5X25MM CANN MAS DBLD SCREW | In distribution |
| 14-571965 | 65MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571740 | 5.5 TI 9.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571009 | 60MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571470 | 5.5 TI 6.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571335C | 5.5 TI 5.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3670J | 8.5X70MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3750J | 9.5X50MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571504 | 5.5 TI 7.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571043 | 360MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3502J | 7.5X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3865J | 10.5X65MM CANN MAS DBLD SCREW | In distribution |
| 2000-3440J | 6.5X40MM CANN MAS DBLD SCREW | In distribution |
| 2000-3290J | 5.0X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3450J | 6.5X50MM CANN MAS DBLD SCREW | In distribution |
| 2000-3308J | 5.5X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3745J | 9.5X45MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571850C | 5.5 TI 10.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571770C | 5.5 TI 9.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571725 | 5.5 TI 9.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3207J | 5.0X135MM CANN MAS DBLD SCREW | In distribution |
| 2000-3705J | 9.5X125MM CANN MAS DBLD SCREW | In distribution |
| 14-571011 | 70MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571730C | 5.5 TI 9.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3875J | 10.5X75MM CANN MAS DBLD SCREW | In distribution |
| 2000-3885J | 10.5X85MM CANN MAS DBLD SCREW | In distribution |
| 2000-3320J | 5.5X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3760J | 9.5X60MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3508J | 7.5X140MM CANN MAS DBLD SCREW | In distribution |
| 2000-3306J | 5.5X130MM CANN MAS DBLD SCREW | In distribution |
| 14-571745 | 5.5 TI 9.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571330C | 5.5 TI 5.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571809 | 5.5 TI 10.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3540J | 7.5X40MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571017 | 100MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571570C | 5.5 TI 7.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571405 | 5.5 TI 6.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3270J | 5.0X70MM CANN MAS DBLD SCREW | In distribution |
| 14-571950 | 50MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571036 | 290MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3480J | 6.5X80MM CANN MAS DBLD SCREW | In distribution |
| 14-571780C | 5.5 TI 9.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571053 | 460MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3570J | 7.5X70MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3555J | 7.5X55MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3695J | 8.5X95MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3710J | 9.5X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3501J | 7.5X105MM CANN MAS DBLD SCREW | In distribution |
| 14-571690 | 5.5 TI 8.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3565J | 7.5X65MM CANN MAS DBLD SCREW | In distribution |
| 14-571705C | 5.5 TI 9.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3504J | 7.5X120MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571355C | 5.5 TI 5.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3208J | 5.0X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571204C | 5.5 TI 5.0X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3775J | 9.5X75MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571655 | 5.5 TI 8.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571275C | 5.5 TI 5.0X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3835J | 10.5X35MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3685J | 8.5X85MM CANN MAS DBLD SCREW | In distribution |
| 14-571860C | 5.5 TI 10.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3875J | 10.5X75MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571980 | 80MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571860 | 5.5 TI 10.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3640J | 8.5X40MM CANN MAS DBLD SCREW | In distribution |
| 14-571555 | 5.5 TI 7.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571850 | 5.5 TI 10.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3205J | 5.0X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571207 | 5.5 TI 5.0X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3501J | 7.5X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571530C | 5.5 TI 7.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571425 | 5.5 TI 6.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3807J | 10.5X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571485C | 5.5 TI 6.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571044 | 370MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3308J | 5.5X140MM CANN MAS DBLD SCREW | In distribution |
| 14-571605 | 5.5 TI 8.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3301J | 5.5X105MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571002 | 25MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571265C | 5.5 TI 5.0X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3720J | 9.5X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571709C | 5.5 TI 9.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3802J | 10.5X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571670C | 5.5 TI 8.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571404C | 5.5 TI 6.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3855J | 10.5X55MM CANN MAS DBLD SCREW | In distribution |
| 2000-3402J | 6.5X110MM CANN MAS DBLD SCREW | In distribution |
| 14-571570 | 5.5 TI 7.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571204 | 5.5 TI 5.0X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571340 | 5.5 TI 5.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571755C | 5.5 TI 9.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3460J | 6.5X60MM CANN MAS DBLD SCREW | In distribution |
| 14-571510C | 5.5 TI 7.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571914 | 140MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3505J | 7.5X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3609J | 8.5X145MM CANN MAS DBLD SCREW | In distribution |
| 14-571201C | 5.5 TI 5.0X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3580J | 7.5X80MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571701 | 5.5 TI 9.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571013 | 80MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571245 | 5.5 TI 5.0X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3735J | 9.5X35MM CANN MAS DBLD SCREW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.