Tangis
Anterior Cervical Plating System, 4.25mm dia. 12mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in…
Anterior Cervical Plating System, 4.25mm dia. 12mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
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 | Nvision Biomedical Technologies, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K161524 |
| Record published | 2017-02-28 |
| Record revised | 2026-07-28 (version 9) |
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 | Height 10 to 92 mm; width 3.75 to 17 mm; depth 1.98 to 4.75 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACP-4-84 | Height 84 mm | In distribution |
| ACP-4-80 | Height 80 mm | In distribution |
| ACP-475-18V | Height 18 mm | In distribution |
| ACP-375-16V | Height 16 mm | In distribution |
| ACP-425-16F | Height 16 mm | In distribution |
| ACP-4-64 | Height 64 mm | In distribution |
| ACP-1-24 | Height 24 mm | In distribution |
| ACP-3-71 | Height 71 mm | In distribution |
| ACP-425-18V | Height 18 mm | In distribution |
| ACP-375-14V | Height 14 mm | In distribution |
| ACP-3-68 | Height 68 mm | In distribution |
| ACP-375-18F | Height 18 mm | In distribution |
| ACP-375-20F | Height 20 mm | In distribution |
| ACP-4-88 | Height 88 mm | In distribution |
| ACP-2-39 | Height 39 mm | In distribution |
| ACP-2-51 | Height 51 mm | In distribution |
| ACP-375-20V | Height 20 mm | In distribution |
| ACP-425-10F | Height 10 mm | In distribution |
| ACP-375-10V | Height 10 mm | In distribution |
| ACP-4-60 | Height 60 mm | In distribution |
| ACP-3-59 | Height 59 mm | In distribution |
| ACP-4-92 | Height 92 mm | In distribution |
| ACP-1-32 | Height 32 mm | In distribution |
| ACP-2-48 | Height 48 mm | In distribution |
| ACP-475-12V | Height 12 mm | In distribution |
| ACP-1-22 | Height 22 mm | In distribution |
| ACP-425-16V | Height 16 mm | In distribution |
| ACP-425-12V | Height 12 mm | In distribution |
| ACP-1-26 | Height 26 mm | In distribution |
| ACP-1-20 | Depth 1.98 mm | In distribution |
| ACP-425-10V | Height 10 mm | In distribution |
| ACP-3-74 | Height 74 mm | In distribution |
| ACP-2-42 | Height 42 mm | In distribution |
| ACP-4-68 | Height 68 mm | In distribution |
| ACP-1-28 | Height 28 mm | In distribution |
| ACP-3-56 | Height 56 mm | In distribution |
| ACP-375-18V | Height 18 mm | In distribution |
| ACP-2-54 | Height 54 mm | In distribution |
| ACP-3-53 | Height 53 mm | In distribution |
| ACP-425-12F | Height 12 mm | In distribution |
| ACP-375-16F | Height 16 mm | In distribution |
| ACP-475-10V | Height 10 mm | In distribution |
| ACP-425-14V | Height 14 mm | In distribution |
| ACP-3-65 | Height 65 mm | In distribution |
| ACP-375-12V | Height 12 mm | In distribution |
| ACP-475-14V | Height 14 mm | In distribution |
| ACP-2-36 | Height 36 mm | In distribution |
| ACP-425-14F | Height 14 mm | In distribution |
| ACP-425-20V | Height 20 mm | In distribution |
| ACP-475-16V | Height 16 mm | In distribution |
| ACP-375-10F | Height 10 mm | In distribution |
| ACP-2-33 | Height 33 mm | In distribution |
| ACP-4-76 | Height 76 mm | In distribution |
| ACP-2-45 | Height 45 mm | In distribution |
| ACP-475-20V | Height 20 mm | In distribution |
| ACP-1-30 | Height 30 mm | In distribution |
| ACP-425-20F | Height 20 mm | In distribution |
| ACP-4-72 | Height 72 mm | In distribution |
| ACP-425-18F | Height 18 mm | In distribution |
| ACP-375-12F | Height 12 mm | In distribution |
| ACP-3-77 | Height 77 mm | In distribution |
| ACP-1-34 | Height 34 mm | In distribution |
| ACP-375-14F | Height 14 mm | In distribution |
| ACP-3-62 | Height 62 mm | 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 |
|---|---|
| K210424 | 2021-10-22 |
| K173091 | 2017-12-06 |
| K161524 | 2016-09-02 |
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.