Emerge Anterior Cervical Plate System
EMERGE is an anterior cervical plate-and-screw system for fixation from C2 through C7. The plate attaches to the front of the cervical vertebral bodies, with screws anchoring the selected…
EMERGE is an anterior cervical plate-and-screw system for fixation from C2 through C7. The plate attaches to the front of the cervical vertebral bodies, with screws anchoring the selected construct.
Plates and bone screws are Ti-6Al-4V ELI titanium alloy. Plate sizes vary to accommodate the spinal levels and anatomical requirements involved.
Listed Item
VARIABLE TAPPING CERVICAL SCREW DIA 4.25 X 26 mm
Screw-Angle Options
The plates accept fixed-angle or variable-angle screws. A listed variable tapping screw is one fastener option within this family. The system’s fixation is anterior; it is not intended for attachment to posterior spinal pedicles.
14manufacturers in China registered for this device type
162catalogue numbers in this listing
4510(k) clearances naming this product code
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) | K212405 |
| Record published | 2021-11-01 |
| Record revised | 2024-09-11 (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 10 to 110 mm; outer diameter 3.8 to 4.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-40FT16 | Outer Diameter 4 mm | In distribution |
| 100-2L36 | Length 36 mm | In distribution |
| 100-2L54 | 2 Level | In distribution |
| 100-40V12 | Length 12 mm | In distribution |
| 100-43V22 | Outer Diameter 4.3 mm | In distribution |
| 100-5L110 | Length 110 mm | In distribution |
| 100-3L67 | Length 67 mm | In distribution |
| 100-1L20 | Length 20 mm | In distribution |
| 100-40V22 | Length 22 mm | In distribution |
| 100-40FT10 | Outer Diameter 4 mm | In distribution |
| 100-1L26 | 1 Level | In distribution |
| 100-3L49 | Length 49 mm | In distribution |
| 100-1L34 | 1 Level | In distribution |
| 100-2L44 | 2 Level | In distribution |
| 100-43F24 | Length 24 mm | In distribution |
| 100-2L50 | Length 50 mm | In distribution |
| 100-3L52 | 3 Level | In distribution |
| 100-38F24 | Fixed, Self-Drilling | In distribution |
| 100-40F16 | Outer Diameter 4 mm | In distribution |
| 100-43VT26 | Length 26 mm | In distribution |
| 100-40FT26 | Fixed, Self-Tapping | In distribution |
| 100-43VT16 | Length 16 mm | In distribution |
| 100-43VT24 | Outer Diameter 4.3 mm | In distribution |
| 100-43F12 | Fixed, Self-Drilling | In distribution |
| 100-1L22 | Length 22 mm | In distribution |
| 100-40V24 | Length 24 mm | In distribution |
| 100-2L40 | Length 40 mm | In distribution |
| 100-40F14 | Outer Diameter 4 mm | In distribution |
| 100-43FT12 | Length 12 mm | In distribution |
| 100-5L95 | 5 Level | In distribution |
| 100-38V22 | Variable, Self-Drilling | In distribution |
| 100-5L105 | 5 Level | In distribution |
| 100-5L75 | Length 75 mm | In distribution |
| 100-40F10 | Fixed, Self-Drilling | In distribution |
| 100-1L28 | 1 Level | In distribution |
| 100-43F16 | Outer Diameter 4.3 mm | In distribution |
| 100-38VT20 | Length 20 mm | In distribution |
| 100-38FT18 | Length 18 mm | In distribution |
| 100-38F18 | Outer Diameter 3.8 mm | In distribution |
| 100-43FT22 | Fixed, Self-Tapping | In distribution |
| 100-38VT18 | Outer Diameter 3.8 mm | In distribution |
| 100-43FT20 | Outer Diameter 4.3 mm | In distribution |
| 100-43VT10 | Outer Diameter 4.3 mm | In distribution |
| 100-43VT20 | Outer Diameter 4.3 mm | In distribution |
| 100-40V16 | Length 16 mm | In distribution |
| 100-38FT14 | Length 14 mm | In distribution |
| 100-1L38 | Length 38 mm | In distribution |
| 100-43F26 | Fixed, Self-Drilling | In distribution |
| 100-43F20 | Length 20 mm | In distribution |
| 100-3L61 | Length 61 mm | In distribution |
| 100-4L54 | 4 Level | In distribution |
| 100-43V10 | Length 10 mm | In distribution |
| 100-40V26 | Outer Diameter 4 mm | In distribution |
| 100-38F12 | Fixed, Self-Drilling | In distribution |
| 100-43VT18 | Outer Diameter 4.3 mm | In distribution |
| 100-38V26 | Length 26 mm | In distribution |
| 100-2L38 | Length 38 mm | In distribution |
| 100-38VT26 | Outer Diameter 3.8 mm | In distribution |
| 100-4L70 | 4 Level | In distribution |
| 100-2L42 | Length 42 mm | In distribution |
| 100-38V14 | Outer Diameter 3.8 mm | In distribution |
| 100-40F22 | Length 22 mm | In distribution |
| 100-38V12 | Length 12 mm | In distribution |
| 100-3L43 | Length 43 mm | In distribution |
| 100-43V26 | Outer Diameter 4.3 mm | In distribution |
| 100-38FT10 | Fixed, Self-Tapping | In distribution |
| 100-43F22 | Outer Diameter 4.3 mm | In distribution |
| 100-4L50 | Length 50 mm | In distribution |
| 100-43FT16 | Length 16 mm | In distribution |
| 100-40VT22 | Outer Diameter 4 mm | In distribution |
| 100-1L18 | 1 Level | In distribution |
| 100-38VT14 | Variable, Self-Tapping | In distribution |
| 100-2L56 | Length 56 mm | In distribution |
| 100-40V20 | Outer Diameter 4 mm | In distribution |
| 100-2L46 | Length 46 mm | In distribution |
| 100-43FT14 | Fixed, Self-Tapping | In distribution |
| 100-40V18 | Length 18 mm | In distribution |
| 100-38F20 | Fixed, Self-Drilling | In distribution |
| 100-43FT10 | Outer Diameter 4.3 mm | In distribution |
| 100-1L30 | Length 30 mm | In distribution |
| 100-5L100 | Length 100 mm | In distribution |
| 100-38VT10 | Variable, Self-Tapping | In distribution |
| 100-2L34 | Length 34 mm | In distribution |
| 100-3L58 | Length 58 mm | In distribution |
| 100-38FT12 | Length 12 mm | In distribution |
| 100-38F22 | Fixed, Self-Drilling | In distribution |
| 100-40F24 | Length 24 mm | In distribution |
| 100-38VT12 | Outer Diameter 3.8 mm | In distribution |
| 100-40F20 | Outer Diameter 4 mm | In distribution |
| 100-43F18 | Outer Diameter 4.3 mm | In distribution |
| 100-40VT16 | Outer Diameter 4 mm | In distribution |
| 100-38F10 | Outer Diameter 3.8 mm | In distribution |
| 100-43V24 | Variable, Self-Drilling | In distribution |
| 100-40F26 | Outer Diameter 4 mm | In distribution |
| 100-40VT26 | Variable, Self-Tapping | In distribution |
| 100-40F12 | Fixed, Self-Drilling | In distribution |
| 100-43FT24 | Fixed, Self-Tapping | In distribution |
| 100-43V20 | Outer Diameter 4.3 mm | In distribution |
| 100-38FT24 | Fixed, Self-Tapping | In distribution |
| 100-3L73 | 3 Level | In distribution |
| 100-40F18 | Length 18 mm | In distribution |
| 100-38VT16 | Variable, Self-Tapping | In distribution |
| 100-40FT12 | Outer Diameter 4 mm | In distribution |
| 100-43F10 | Length 10 mm | In distribution |
| 100-43V18 | Outer Diameter 4.3 mm | In distribution |
| 100-43FT18 | Fixed, Self-Tapping | In distribution |
| 100-40VT20 | Outer Diameter 4 mm | In distribution |
| 100-43V12 | Outer Diameter 4.3 mm | In distribution |
| 100-3L46 | 3 Level | In distribution |
| 100-5L80 | 5 Level | In distribution |
| 100-43V14 | Variable, Self-Drilling | In distribution |
| 100-40V10 | Variable, Self-Drilling | In distribution |
| 100-1L24 | 1 Level | In distribution |
| 100-40VT10 | Outer Diameter 4 mm | In distribution |
| 100-4L86 | 4 Level | In distribution |
| 100-38FT16 | Outer Diameter 3.8 mm | In distribution |
| 100-4L58 | Length 58 mm | In distribution |
| 100-3L55 | Length 55 mm | In distribution |
| 100-2L48 | 2 Level | In distribution |
| 100-1L36 | Length 36 mm | In distribution |
| 100-40FT14 | Outer Diameter 4 mm | In distribution |
| 100-4L90 | 4 Level | In distribution |
| 100-4L82 | Length 82 mm | In distribution |
| 100-4L78 | 4 Level | In distribution |
| 100-38FT22 | Outer Diameter 3.8 mm | In distribution |
| 100-43VT12 | Outer Diameter 4.3 mm | In distribution |
| 100-38V20 | Length 20 mm | In distribution |
| 100-38F16 | Outer Diameter 3.8 mm | In distribution |
| 100-38V16 | Outer Diameter 3.8 mm | In distribution |
| 100-38F14 | Outer Diameter 3.8 mm | In distribution |
| 100-4L66 | Length 66 mm | In distribution |
| 100-40FT22 | Outer Diameter 4 mm | In distribution |
| 100-5L90 | Length 90 mm | In distribution |
| 100-5L85 | 5 Level | In distribution |
| 100-38FT20 | Outer Diameter 3.8 mm | In distribution |
| 100-3L70 | 3 Level | In distribution |
| 100-2L52 | Length 52 mm | In distribution |
| 100-43FT26 | Fixed, Self-Tapping | In distribution |
| 100-38VT24 | Variable, Self-Tapping | In distribution |
| 100-38F26 | Fixed, Self-Drilling | In distribution |
| 100-1L32 | Length 32 mm | In distribution |
| 100-38V18 | Outer Diameter 3.8 mm | In distribution |
| 100-40VT14 | Length 14 mm | In distribution |
| 100-43F14 | Length 14 mm | In distribution |
| 100-40VT18 | Variable, Self-Tapping | In distribution |
| 100-40FT24 | Outer Diameter 4 mm | In distribution |
| 100-43VT22 | Variable, Self-Tapping | In distribution |
| 100-38FT26 | Length 26 mm | In distribution |
| 100-2L32 | 2 Level | In distribution |
| 100-40FT18 | Outer Diameter 4 mm | In distribution |
| 100-40VT12 | Variable, Self-Tapping | In distribution |
| 100-40V14 | Length 14 mm | In distribution |
| 100-4L74 | 4 Level | In distribution |
| 100-38V24 | Outer Diameter 3.8 mm | In distribution |
| 100-38VT22 | Variable, Self-Tapping | In distribution |
| 100-4L62 | Length 62 mm | In distribution |
| 100-40VT24 | Variable, Self-Tapping | In distribution |
| 100-38V10 | Outer Diameter 3.8 mm | In distribution |
| 100-3L64 | 3 Level | In distribution |
| 100-43V16 | Variable, Self-Drilling | In distribution |
| 100-40FT20 | Length 20 mm | In distribution |
| 100-43VT14 | Length 14 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 |
|---|---|
| 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.