Emerge Micro Anterior Cervical Plate System
The EMERGE anterior cervical plate attaches to the front of cervical vertebral bodies using bone screws. The system provides anterior screw fixation from C2 to C7 and offers plates in…
The EMERGE anterior cervical plate attaches to the front of cervical vertebral bodies using bone screws. The system provides anterior screw fixation from C2 to C7 and offers plates in different sizes to accommodate anatomy and surgical needs.
The plates and screws are made from Ti-6Al-4V ELI titanium alloy. Plates can be used with fixed angle or variable angle screws, providing alternative screw configurations within the anterior plate system.
Listed Item
2 LEVEL PLATE 22mm
Indications and Placement
Indications include degenerative disc disease, trauma, tumors, deformity, failed fusion, spondylolisthesis and spinal stenosis. The system is not intended for attachment to the posterior spinal elements or pedicles of the cervical, thoracic or lumbar spine.
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 | Evolution Spine, LLC, 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) | K220275 |
| Record published | 2022-06-10 |
| Record revised | 2025-11-20 (version 3) |
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 5 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-2L22 | Length 22 mm | In distribution |
| 101-2L20 | Length 20 mm | In distribution |
| 101-2L14 | 2 Level | In distribution |
| 101-2L26 | Length 26 mm | In distribution |
| 101-2L28 | 2 Level | In distribution |
| 101-1L10 | Length 10 mm | In distribution |
| 101-1L09 | Length 9 mm | In distribution |
| 101-2L24 | 2 Level | In distribution |
| 101-2L16 | Length 16 mm | In distribution |
| 101-2L30 | Length 30 mm | In distribution |
| 101-1L05 | Length 5 mm | In distribution |
| 101-1L06 | 1 Level | In distribution |
| 101-1L07 | Length 7 mm | In distribution |
| 101-1L11 | 1 Level | In distribution |
| 101-2L18 | 2 Level | In distribution |
| 101-1L12 | 1 Level | In distribution |
| 101-1L08 | 1 Level | 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 |
|---|---|
| K220275 | 2022-03-18 |
| K212405 | 2021-09-30 |
| K180755 | 2018-07-06 |
| K173375 | 2017-12-21 |
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.