Ni-Lock® Anterior Cervical Plate System
Screw Variable Self-Drilling 3.75mm x 12mm
14manufacturers in China registered for this device type
73catalogue numbers in this listing
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 | Spine Wave, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K091926 |
| Record published | 2015-10-24 |
| Record revised | 2024-09-11 (version 5) |
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 |
| Sizes | Length 10 to 20 mm; outer diameter 3.75 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-R414 | Length 14 mm | In distribution |
| 15-3044 | In distribution | |
| 15-H420 | Length 20 mm | In distribution |
| 15-2024 | In distribution | |
| 15-2036 | In distribution | |
| 15-R418 | Length 18 mm | In distribution |
| 15-F416 | Length 16 mm | In distribution |
| 15-N410 | Outer Diameter 4.5 mm | In distribution |
| 15-P418 | Outer Diameter 4.0 mm | In distribution |
| 15-R416 | Outer Diameter 4.0 mm | In distribution |
| 15-N416 | Length 16 mm | In distribution |
| 15-F410 | Outer Diameter 4.0 mm | In distribution |
| 15-E412 | Length 12 mm | In distribution |
| 15-2022 | In distribution | |
| 15-F414 | Outer Diameter 4.0 mm | In distribution |
| 15-E416 | Length 16 mm | In distribution |
| 15-P416 | Length 16 mm | In distribution |
| 15-1014 | In distribution | |
| 15-3048 | In distribution | |
| 15-H418 | Outer Diameter 4.0 mm | In distribution |
| 15-R410 | Length 10 mm | In distribution |
| 15-3050 | In distribution | |
| 15-2032 | In distribution | |
| 15-L416 | Length 16 mm | In distribution |
| 15-N418 | Outer Diameter 4.5 mm | In distribution |
| 15-E414 | Outer Diameter 3.75 mm | In distribution |
| 15-4072 | In distribution | |
| 15-F418 | Outer Diameter 4.0 mm | In distribution |
| 15-3054 | In distribution | |
| 15-4076 | In distribution | |
| 15-1018 | In distribution | |
| 15-R420 | Outer Diameter 4.0 mm | In distribution |
| 15-2040 | In distribution | |
| 15-2020 | In distribution | |
| 15-L420 | Length 20 mm | In distribution |
| 15-L418 | Outer Diameter 4.5 mm | In distribution |
| 15-L412 | Length 12 mm | In distribution |
| 15-F420 | Length 20 mm | In distribution |
| 15-3062 | In distribution | |
| 15-N412 | Length 12 mm | In distribution |
| 15-P420 | Length 20 mm | In distribution |
| 15-L410 | Outer Diameter 4.5 mm | In distribution |
| 15-H416 | Length 16 mm | In distribution |
| 15-L414 | Outer Diameter 4.5 mm | In distribution |
| 15-4060 | In distribution | |
| 15-P414 | Outer Diameter 4.0 mm | In distribution |
| 15-1024 | In distribution | |
| 15-2030 | In distribution | |
| 15-3058 | In distribution | |
| 15-3040 | In distribution | |
| 15-2026 | In distribution | |
| 15-4084 | In distribution | |
| 15-H410 | Outer Diameter 4.0 mm | In distribution |
| 15-P410 | Outer Diameter 4.0 mm | In distribution |
| 15-1020 | In distribution | |
| 15-2044 | In distribution | |
| 15-1016 | In distribution | |
| 15-N420 | Length 20 mm | In distribution |
| 15-H412 | Length 12 mm | In distribution |
| 15-1026 | In distribution | |
| 15-1012 | In distribution | |
| 15-4068 | In distribution | |
| 15-H414 | Outer Diameter 4.0 mm | In distribution |
| 15-P412 | Length 12 mm | In distribution |
| 15-N414 | Outer Diameter 4.5 mm | In distribution |
| 15-4080 | In distribution | |
| 15-F412 | Length 12 mm | In distribution |
| 15-4064 | In distribution | |
| 15-2028 | In distribution | |
| 15-R412 | Outer Diameter 4.0 mm | In distribution |
| 15-2034 | In distribution | |
| 15-1010 | In distribution | |
| 15-1022 | 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
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.