Asfora Anterior Cervical Plate System
Asfora Anterior Cervical Plate System temporarily stabilizes the anterior cervical spine from C2 to T1 during fusion. Plate lengths accommodate one to four levels, with three locking tabs…
Asfora Anterior Cervical Plate System temporarily stabilizes the anterior cervical spine from C2 to T1 during fusion. Plate lengths accommodate one to four levels, with three locking tabs intended to reduce screw backout.
Fixed-angle and variable-angle implant screws have 4.0 mm diameters; rescue screws are 4.4 mm. Screw lengths include 12, 14 and 16 mm. Plates are pre-lordosed with a 190 mm radius.
Listed Item
2 Level, 38mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Treatment Indications
Uses include degenerative disc disease, spondylolisthesis, fractures or dislocations, spinal stenosis, deformity, tumor, pseudarthrosis and failed prior fusion. Discogenic neck pain with degeneration confirmed by patient history and imaging defines the degenerative disc disease indication.
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 | Medical Designs, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K143688 |
| Record published | 2016-09-27 |
| Record revised | 2024-09-11 (version 7) |
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 |
|---|---|---|
| 11-1106-FD2-38 | In distribution | |
| 11-1106-FD3-57 | In distribution | |
| 11-1106-FD14 | In distribution | |
| 11-1106-FD2-50 | In distribution | |
| 11-1106-FD16 | In distribution | |
| 11-1106-FD43 | In distribution | |
| 11-1106-FD1-22 | In distribution | |
| 11-1106-FD1-24 | In distribution | |
| 11-1106-FD2-32 | In distribution | |
| 11-1106-FD4-74 | In distribution | |
| 11-1106-FD2-44 | In distribution | |
| 11-1106-FD1-34 | In distribution | |
| 11-1106-FD9-14 | In distribution | |
| 11-1106-FD7-12 | In distribution | |
| 11-1106-FD1-30 | In distribution | |
| 11-1106-FD9-16 | In distribution | |
| 11-1106-FD3-54 | In distribution | |
| 11-1106-FD28 | In distribution | |
| 11-1106-FD27-2 | In distribution | |
| 11-1106-FD3-72 | In distribution | |
| 11-1106-FD12 | In distribution | |
| 11-1106-FD4-86 | In distribution | |
| 11-1106-FD3-63 | In distribution | |
| 11-1106-FD36 | In distribution | |
| 11-1106-FD27-1 | In distribution | |
| 11-1106-FD3-69 | In distribution | |
| 11-1106-FD1-32 | In distribution | |
| 11-1106-FD9-12 | In distribution | |
| 11-1106-FD7-14 | In distribution | |
| 11-1106-FD8-16 | In distribution | |
| 11-1106-FD27-3 | In distribution | |
| 11-1106-FD41 | In distribution | |
| 11-1106-FD4-82 | In distribution | |
| 11-1106-FD4-90 | In distribution | |
| 11-1106-FD1-20 | In distribution | |
| 11-1106-FD2-47 | In distribution | |
| 11-1106-FD42 | In distribution | |
| 11-1106-FD3-51 | In distribution | |
| 11-1106-FD3-66 | In distribution | |
| 11-1106-FD4-78 | In distribution | |
| 11-1106-FD8-12 | In distribution | |
| 11-1106-FD1-28 | In distribution | |
| 11-1106-FD37 | In distribution | |
| 11-1106-FD35 | In distribution | |
| 11-1106-FD3-60 | In distribution | |
| 11-1106-FD3-75 | In distribution | |
| 11-1106-FD1-26 | In distribution | |
| 11-1106-FD7-16 | In distribution | |
| 11-1106-FD4-94 | In distribution | |
| 11-1106-FD2-41 | In distribution | |
| 11-1106-FD2-35 | In distribution | |
| 11-1106-FD8-14 | In distribution | |
| 11-1106-FD29 | 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 |
|---|---|
| K143688 | 2015-07-01 |
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.