Cypher™ MIS System
161 catalogue numbers from 14-571050, 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
161catalogue 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 | 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 |
|---|---|---|
| 14-571050 | 430MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571058 | 510MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571885 | 5.5 TI 10.5X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3350J | 5.5X50MM CANN MAS DBLD SCREW | In distribution |
| 2000-3525J | 7.5X25MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3605J | 8.5X125MM CANN MAS DBLD SCREW | In distribution |
| 2000-3407J | 6.5X135MM CANN MAS DBLD SCREW | In distribution |
| 14-571409C | 5.5 TI 6.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571580 | 5.5 TI 7.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571890C | 5.5 TI 10.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571270C | 5.5 TI 5.0X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571875C | 5.5 TI 10.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3870J | 10.5X70MM CANN MAS DBLD SCREW | In distribution |
| 14-571525C | 5.5 TI 7.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571509 | 5.5 TI 7.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571804 | 5.5 TI 10.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571302C | 5.5 TI 5.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3595J | 7.5X95MM CANN MAS DBLD SCREW | In distribution |
| 14-571025 | 180MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3780J | 9.5X80MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571210C | 5.5 TI 5.0X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571845 | 5.5 TI 10.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571603C | 5.5 TI 8.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3708J | 9.5X140MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571299C | 5.5 TI 5.0X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3265J | 5.0X65MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571440C | 5.5 TI 6.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571255C | 5.5 TI 5.0X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3507J | 7.5X135MM CANN MAS DBLD SCREW | In distribution |
| 2000-3420J | 6.5X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571041 | 340MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3510J | 7.5X150MM CANN MAS DBLD SCREW | In distribution |
| 14-571590 | 5.5 TI 7.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571575 | 5.5 TI 7.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3604J | 8.5X120MM CANN MAS DBLD SCREW | In distribution |
| 2000-3330J | 5.5X30MM CANN MAS DBLD SCREW | In distribution |
| 14-571675 | 5.5 TI 8.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3890J | 10.5X90MM CANN MAS DBLD SCREW | In distribution |
| 2000-3890J | 10.5X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3340J | 5.5X40MM CANN MAS DBLD SCREW | In distribution |
| 2000-3805J | 10.5X125MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571403 | 5.5 TI 6.5X115MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571299 | 5.5 TI 5.0X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571899C | 5.5 TI 10.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571535C | 5.5 TI 7.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571499C | 5.5 TI 6.5X100MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571895 | 5.5 TI 10.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3304J | 5.5X120MM CANN MAS DBLD SCREW | In distribution |
| 14-571705 | 5.5 TI 9.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3385J | 5.5X85MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571520 | 5.5 TI 7.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571704C | 5.5 TI 9.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571365 | 5.5 TI 5.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3790J | 9.5X90MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3410J | 6.5X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3207J | 5.0X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3708J | 9.5X140MM CANN MAS DBLD SCREW | In distribution |
| 14-571607 | 5.5 TI 8.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571640C | 5.5 TI 8.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3360J | 5.5X60MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3806J | 10.5X130MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571608 | 5.5 TI 8.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3610J | 8.5X150MM CANN MAS DBLD SCREW | In distribution |
| 14-571502C | 5.5 TI 7.5X110MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3603J | 8.5X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3407J | 6.5X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571440 | 5.5 TI 6.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571580C | 5.5 TI 7.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3555J | 7.5X55MM CANN MAS DBLD SCREW | In distribution |
| 2000-3665J | 8.5X65MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3355J | 5.5X55MM CANN MAS DBLD SCREW | In distribution |
| 14-571604 | 5.5 TI 8.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3310J | 5.5X150MM CANN MAS DBLD SCREW | In distribution |
| 2000-3635J | 8.5X35MM CANN MAS DBLD SCREW | In distribution |
| 14-571475 | 5.5 TI 6.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571505C | 5.5 TI 7.5X125MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571955 | 55MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571650C | 5.5 TI 8.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3580J | 7.5X80MM CANN MAS DBLD SCREW | In distribution |
| 14-571380C | 5.5 TI 5.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3825J | 10.5X25MM CANN MAS DBLD SCREW | In distribution |
| 2000-3303J | 5.5X115MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571040 | 330MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3301J | 5.5X105MM CANN MAS DBLD SCREW | In distribution |
| 14-571610C | 5.5 TI 8.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3530J | 7.5X30MM CANN MAS DBLD SCREW | In distribution |
| 14-571755 | 5.5 TI 9.5X55MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571475C | 5.5 TI 6.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571365C | 5.5 TI 5.5X65MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3204J | 5.0X120MM CANN MAS DBLD SCREW | In distribution |
| 2000-3405J | 6.5X125MM CANN MAS DBLD SCREW | In distribution |
| 14-571049 | 420MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 2000-3505J | 7.5X125MM CANN MAS DBLD SCREW | In distribution |
| 2000-3765J | 9.5X65MM CANN MAS DBLD SCREW | In distribution |
| 2000-3250J | 5.0X50MM CANN MAS DBLD SCREW | In distribution |
| 14-571016 | 95MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571935 | 35MM CURVED ROD, 5.5 MIS TI | In distribution |
| 2000-3385J | 5.5X85MM CANN MAS DBLD SCREW | In distribution |
| 14-571285C | 5.5 TI 5.0X85MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571740C | 5.5 TI 9.5X40MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571270 | 5.5 TI 5.0X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571720 | 5.5 TI 9.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3602J | 8.5X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3865J | 10.5X65MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571708 | 5.5 TI 9.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3360J | 5.5X60MM CANN MAS DBLD SCREW | In distribution |
| 14-571609 | 5.5 TI 8.5X145MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571045 | 380MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571280C | 5.5 TI 5.0X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571490C | 5.5 TI 6.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571925 | 25MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571370C | 5.5 TI 5.5X70MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3840J | 10.5X40MM CANN MAS DBLD SCREW | In distribution |
| 14-571018 | 110MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571825C | 5.5 TI 10.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3660J | 8.5X60MM CANN MAS DBLD SCREW | In distribution |
| 14-571504C | 5.5 TI 7.5X120MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571039 | 320MM STRAIGHT ROD, 5.5 MIS TI | In distribution |
| 14-571990 | 90MM CURVED ROD, 5.5 MIS TI | In distribution |
| 14-571750C | 5.5 TI 9.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3510J | 7.5X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571301 | 5.5 TI 5.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3607J | 8.5X135MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3206J | 5.0X130MM CANN MAS DBLD SCREW | In distribution |
| 14-571735C | 5.5 TI 9.5X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3703J | 9.5X115MM CANN MAS DBLD SCREW | In distribution |
| 14-571880C | 5.5 TI 10.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571625C | 5.5 TI 8.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571345C | 5.5 TI 5.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571307 | 5.5 TI 5.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3645J | 8.5X45MM CANN MAS DBLD SCREW | In distribution |
| 2000-3380J | 5.5X80MM CANN MAS DBLD SCREW | In distribution |
| 14-571550C | 5.5 TI 7.5X50MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3675J | 8.5X75MM CANN MAS DBLD SCREW | In distribution |
| 14-571760C | 5.5 TI 9.5X60MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3202J | 5.0X110MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571320C | 5.5 TI 5.5X20MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3620J | 8.5X20MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571810C | 5.5 TI 10.5X150MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571790C | 5.5 TI 9.5X90MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571730 | 5.5 TI 9.5X30MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3740J | 9.5X40MM CANN MAS DBLD SCREW | In distribution |
| 14-571425C | 5.5 TI 6.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3495J | 6.5X95MM CANN MAS DBLD SCREW | In distribution |
| 2000-3699J | 8.5X100MM CANN MAS DBLD SCREW | In distribution |
| 14-571480 | 5.5 TI 6.5X80MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571407 | 5.5 TI 6.5X135MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571235 | 5.5 TI 5.0X35MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571675C | 5.5 TI 8.5X75MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3808J | 10.5X140MM CANN MAS DBLD SCREW | In distribution |
| 14-571545 | 5.5 TI 7.5X45MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3210J | 5.0X150MM CANN MAS DBLD SCREW | In distribution |
| 2000-3870J | 10.5X70MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 2000-3210J | 5.0X150MM CANN MAS DBLD SCREW CYPHER MIS SYSTEM | In distribution |
| 14-571508 | 5.5 TI 7.5X140MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571325C | 5.5 TI 5.5X25MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3535J | 7.5X35MM CANN MAS DBLD SCREW | In distribution |
| 14-571501C | 5.5 TI 7.5X105MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 14-571795C | 5.5 TI 9.5X95MM CANN TRANS CANNULATED TRANSLATION SCREW | In distribution |
| 2000-3309J | 5.5X145MM CANN MAS DBLD SCREW | In distribution |
| 14-571230C | 5.5 TI 5.0X30MM CANN TRANS CANNULATED TRANSLATION SCREW | 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.