Cypher MIS Screw System
59 catalogue numbers from 14-571340C, 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
59catalogue 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 | 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 |
|---|---|---|
| 14-571340C | 5.5 TI 5.5X40MM CANN TRANS | In distribution |
| 14-571360C | 5.5 TI 5.5X60MM CANN TRANS | In distribution |
| 14-571870C | 5.5 TI 10.5X70MM CANN TRANS | In distribution |
| 14-571940 | 40MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571507C | 5.5 TI 7.5X135MM CANN TRANS | In distribution |
| 14-571046 | 390MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571036 | 290MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571670C | 5.5 TI 8.5X70MM CANN TRANS | In distribution |
| 14-571665C | 5.5 TI 8.5X65MM CANN TRANS | In distribution |
| 14-571799C | 5.5 TI 9.5X100MM CANN TRANS | In distribution |
| 14-571031 | 240MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571275C | 5.5 TI 5.0X75MM CANN TRANS | In distribution |
| 14-571203C | 5.5 TI 5.0X115MM CANN TRANS | In distribution |
| 14-571409C | 5.5 TI 6.5X145MM CANN TRANS | In distribution |
| 14-571390C | 5.5 TI 5.5X90MM CANN TRANS | In distribution |
| 14-571755C | 5.5 TI 9.5X55MM CANN TRANS | In distribution |
| 14-571960 | 60MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571047 | 400MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571499C | 5.5 TI 6.5X100MM CANN TRANS | In distribution |
| 14-571250C | 5.5 TI 5.0X50MM CANN TRANS | In distribution |
| 14-571370C | 5.5 TI 5.5X70MM CANN TRANS | In distribution |
| 14-571550C | 5.5 TI 7.5X50MM CANN TRANS | In distribution |
| 14-571695C | 5.5 TI 8.5X95MM CANN TRANS | In distribution |
| 14-571399C | 5.5 TI 5.5X100MM CANN TRANS | In distribution |
| 14-571005 | 40MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571835C | 5.5 TI 10.5X35MM CANN TRANS | In distribution |
| 14-571420C | 5.5 TI 6.5X20MM CANN TRANS | In distribution |
| 14-571026 | 190MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571475C | 5.5 TI 6.5X75MM CANN TRANS | In distribution |
| 14-571240C | 5.5 TI 5.0X40MM CANN TRANS | In distribution |
| 14-571509C | 5.5 TI 7.5X145MM CANN TRANS | In distribution |
| 14-571650C | 5.5 TI 8.5X50MM CANN TRANS | In distribution |
| 14-571042 | 350MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571820C | 5.5 TI 10.5X20MM CANN TRANS | In distribution |
| 14-571206C | 5.5 TI 5.0X130MM CANN TRANS | In distribution |
| 14-571535C | 5.5 TI 7.5X35MM CANN TRANS | In distribution |
| 14-571455C | 5.5 TI 6.5X55MM CANN TRANS | In distribution |
| 14-571008 | 55MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571037 | 300MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571299C | 5.5 TI 5.0X100MM CANN TRANS | In distribution |
| 14-571050 | 430MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571605C | 5.5 TI 8.5X125MM CANN TRANS | In distribution |
| 14-571570C | 5.5 TI 7.5X70MM CANN TRANS | In distribution |
| 14-571305C | 5.5 TI 5.5X125MM CANN TRANS | In distribution |
| 14-571707C | 5.5 TI 9.5X135MM CANN TRANS | In distribution |
| 14-571735C | 5.5 TI 9.5X35MM CANN TRANS | In distribution |
| 14-571385C | 5.5 TI 5.5X85MM CANN TRANS | In distribution |
| 14-571040 | 330MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571630C | 5.5 TI 8.5X30MM CANN TRANS | In distribution |
| 14-571675C | 5.5 TI 8.5X75MM CANN TRANS | In distribution |
| 14-571801C | 5.5 TI 10.5X105MM CANN TRANS | In distribution |
| 14-571730C | 5.5 TI 9.5X30MM CANN TRANS | In distribution |
| 14-571044 | 370MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571660C | 5.5 TI 8.5X60MM CANN TRANS | In distribution |
| 14-571490C | 5.5 TI 6.5X90MM CANN TRANS | In distribution |
| 14-571555C | 5.5 TI 7.5X55MM CANN TRANS | In distribution |
| 14-571470C | 5.5 TI 6.5X70MM CANN TRANS | In distribution |
| 14-571260C | 5.5 TI 5.0X60MM CANN TRANS | In distribution |
| 14-571525C | 5.5 TI 7.5X25MM CANN TRANS | 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.