Cypher MIS Screw System
38 catalogue numbers from 14-571355C, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
38catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 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 |
|---|---|---|
| 14-571355C | 5.5 TI 5.5X55MM CANN TRANS | In distribution |
| 14-571503C | 5.5 TI 7.5X115MM CANN TRANS | In distribution |
| 14-571013 | 80MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571201C | 5.5 TI 5.0X105MM CANN TRANS | In distribution |
| 14-571585C | 5.5 TI 7.5X85MM CANN TRANS | In distribution |
| 14-571028 | 210MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571202C | 5.5 TI 5.0X110MM CANN TRANS | In distribution |
| 14-571024 | 170MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571365C | 5.5 TI 5.5X65MM CANN TRANS | In distribution |
| 14-571230C | 5.5 TI 5.0X30MM CANN TRANS | In distribution |
| 14-571330C | 5.5 TI 5.5X30MM CANN TRANS | In distribution |
| 14-571285C | 5.5 TI 5.0X85MM CANN TRANS | In distribution |
| 14-571054 | 470MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571609C | 5.5 TI 8.5X145MM CANN TRANS | In distribution |
| 14-571701C | 5.5 TI 9.5X105MM CANN TRANS | In distribution |
| 14-571335C | 5.5 TI 5.5X35MM CANN TRANS | In distribution |
| 14-571205C | 5.5 TI 5.0X125MM CANN TRANS | In distribution |
| 14-571022 | 150MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571780C | 5.5 TI 9.5X80MM CANN TRANS | In distribution |
| 14-571402C | 5.5 TI 6.5X110MM CANN TRANS | In distribution |
| 14-571017 | 100MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571775C | 5.5 TI 9.5X75MM CANN TRANS | In distribution |
| 14-571750C | 5.5 TI 9.5X50MM CANN TRANS | In distribution |
| 14-571655C | 5.5 TI 8.5X55MM CANN TRANS | In distribution |
| 14-571795C | 5.5 TI 9.5X95MM CANN TRANS | In distribution |
| 14-571480C | 5.5 TI 6.5X80MM CANN TRANS | In distribution |
| 14-571885C | 5.5 TI 10.5X85MM CANN TRANS | In distribution |
| 14-571620C | 5.5 TI 8.5X20MM CANN TRANS | In distribution |
| 14-571406C | 5.5 TI 6.5X130MM CANN TRANS | In distribution |
| 14-571970 | 70MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571945 | 45MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571745C | 5.5 TI 9.5X45MM CANN TRANS | In distribution |
| 14-571699C | 5.5 TI 8.5X100MM CANN TRANS | In distribution |
| 14-571575C | 5.5 TI 7.5X75MM CANN TRANS | In distribution |
| 14-571006 | 45MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571058 | 510MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571607C | 5.5 TI 8.5X135MM CANN TRANS | In distribution |
| 14-571865C | 5.5 TI 10.5X65MM CANN TRANS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.