Mecta-C Cervical Plate System
Mecta-C is an anterior cervical plate-and-screw system for temporary stabilization during fusion. The plate attaches to the vertebral bodies, with single-level and multilevel configurations…
Mecta-C is an anterior cervical plate-and-screw system for temporary stabilization during fusion. The plate attaches to the vertebral bodies, with single-level and multilevel configurations extending up to four levels.
The titanium alloy screws have an outer main shaft and an inner locking screw. Fixed-angle and variable-angle versions are offered, with self-tapping or self-drilling tips.
Listed Item
Unsterile variable self-tapping screw diam. 4.5x14mm
Plate and Supply Options
Plate lengths and screw dimensions vary within the range to accommodate the fixation construct. Plates and screws are available sterile or nonsterile, and the system is intended for anterior cervical interbody fixation from C2 through T1.
14manufacturers in China registered for this device type
286catalogue numbers in this listing
1510(k) clearance
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 | Medacta International SA, Switzerland |
|---|---|
| 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, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140361 |
| Record published | 2014-11-18 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.71.010 | In distribution | |
| 03.70.275 | In distribution | |
| 03.71.080 | In distribution | |
| 03.71.265 | In distribution | |
| 03.70.011 | In distribution | |
| 03.70.155 | In distribution | |
| 03.70.096 | In distribution | |
| 03.70.278 | In distribution | |
| 03.70.170 | In distribution | |
| 03.70.047 | In distribution | |
| 03.70.246 | In distribution | |
| 03.70.031 | In distribution | |
| 03.70.062 | In distribution | |
| 03.70.140 | In distribution | |
| 03.70.149 | In distribution | |
| 03.71.468 | In distribution | |
| 03.70.277 | In distribution | |
| 03.70.037 | In distribution | |
| 03.70.266 | In distribution | |
| 03.70.074 | In distribution | |
| 03.70.067 | In distribution | |
| 03.71.367 | In distribution | |
| 03.70.286 | In distribution | |
| 03.70.008 | In distribution | |
| 03.70.054 | In distribution | |
| 03.71.002 | In distribution | |
| 03.71.003 | In distribution | |
| 03.70.049 | In distribution | |
| 03.70.066 | In distribution | |
| 03.70.396 | In distribution | |
| 03.70.017 | In distribution | |
| 03.70.422 | In distribution | |
| 03.70.167 | In distribution | |
| 03.70.288 | In distribution | |
| 03.70.108 | In distribution | |
| 03.70.148 | In distribution | |
| 03.70.406 | In distribution | |
| 03.70.065 | In distribution | |
| 03.71.246 | In distribution | |
| 03.70.296 | In distribution | |
| 03.70.070 | In distribution | |
| 03.70.150 | In distribution | |
| 03.70.287 | In distribution | |
| 03.70.029 | In distribution | |
| 03.70.269 | In distribution | |
| 03.70.028 | In distribution | |
| 03.70.390 | In distribution | |
| 03.71.270 | In distribution | |
| 03.71.005 | In distribution | |
| 03.70.392 | In distribution | |
| 03.70.264 | In distribution | |
| 03.70.142 | In distribution | |
| 03.70.141 | In distribution | |
| 03.70.270 | In distribution | |
| 03.70.124 | In distribution | |
| 03.70.252 | In distribution | |
| 03.70.068 | In distribution | |
| 03.71.240 | In distribution | |
| 03.71.142 | In distribution | |
| 03.70.240 | In distribution | |
| 03.70.145 | In distribution | |
| 03.71.476 | In distribution | |
| 03.70.261 | In distribution | |
| 03.70.352 | In distribution | |
| 03.70.084 | In distribution | |
| 03.70.033 | In distribution | |
| 03.71.392 | In distribution | |
| 03.71.364 | In distribution | |
| 03.70.281 | In distribution | |
| 03.71.145 | In distribution | |
| 03.70.024 | In distribution | |
| 03.70.426 | In distribution | |
| 03.70.014 | In distribution | |
| 03.71.268 | In distribution | |
| 03.70.005 | In distribution | |
| 03.70.078 | In distribution | |
| 03.70.106 | In distribution | |
| 03.70.130 | In distribution | |
| 03.70.158 | In distribution | |
| 03.71.126 | In distribution | |
| 03.70.157 | In distribution | |
| 03.71.007 | In distribution | |
| 03.70.274 | In distribution | |
| 03.71.237 | In distribution | |
| 03.71.078 | In distribution | |
| 03.70.289 | In distribution | |
| 03.70.147 | In distribution | |
| 03.71.269 | In distribution | |
| 03.71.358 | In distribution | |
| 03.70.080 | In distribution | |
| 03.70.376 | In distribution | |
| 03.71.143 | In distribution | |
| 03.71.394 | In distribution | |
| 03.70.100 | In distribution | |
| 03.71.398 | In distribution | |
| 03.70.046 | In distribution | |
| 03.70.040 | In distribution | |
| 03.71.088 | In distribution | |
| 03.71.144 | In distribution | |
| 03.70.053 | In distribution | |
| 03.71.361 | In distribution | |
| 03.71.041 | In distribution | |
| 03.70.283 | In distribution | |
| 03.71.006 | In distribution | |
| 03.70.072 | In distribution | |
| 03.71.252 | In distribution | |
| 03.70.061 | In distribution | |
| 03.70.114 | In distribution | |
| 03.71.267 | In distribution | |
| 03.70.063 | In distribution | |
| 03.71.141 | In distribution | |
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| 03.70.355 | In distribution | |
| 03.71.352 | In distribution | |
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| 03.71.048 | In distribution | |
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| 03.70.154 | In distribution | |
| 03.70.153 | In distribution | |
| 03.70.280 | In distribution | |
| 03.71.122 | In distribution | |
| 03.70.428 | In distribution | |
| 03.70.370 | In distribution | |
| 03.71.370 | In distribution | |
| 03.70.134 | In distribution | |
| 03.71.396 | In distribution | |
| 03.70.086 | In distribution | |
| 03.70.032 | In distribution | |
| 03.71.264 | In distribution | |
| 03.71.484 | In distribution | |
| 03.70.020 | In distribution | |
| 03.70.398 | In distribution | |
| 03.70.161 | In distribution | |
| 03.70.003 | In distribution | |
| 03.70.126 | In distribution | |
| 03.70.394 | In distribution | |
| 03.71.084 | In distribution | |
| 03.70.112 | In distribution | |
| 03.71.263 | In distribution | |
| 03.71.262 | In distribution | |
| 03.70.156 | In distribution | |
| 03.70.480 | In distribution | |
| 03.71.488 | In distribution | |
| 03.70.166 | In distribution | |
| 03.71.149 | In distribution | |
| 03.70.424 | In distribution | |
| 03.71.400 | In distribution | |
| 03.70.058 | In distribution | |
| 03.71.266 | In distribution | |
| 03.71.376 | In distribution | |
| 03.70.050 | In distribution | |
| 03.70.472 | In distribution | |
| 03.70.162 | In distribution | |
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| 03.70.291 | In distribution | |
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| 03.70.476 | In distribution | |
| 03.70.023 | In distribution | |
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| 03.70.042 | In distribution | |
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| 03.70.263 | In distribution | |
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| 03.71.082 | In distribution | |
| 03.71.492 | In distribution | |
| 03.70.056 | In distribution | |
| 03.70.410 | In distribution | |
| 03.70.364 | In distribution | |
| 03.71.147 | In distribution | |
| 03.70.282 | In distribution | |
| 03.70.265 | In distribution | |
| 03.71.050 | In distribution | |
| 03.71.234 | In distribution | |
| 03.70.045 | In distribution | |
| 03.71.261 | In distribution | |
| 03.71.009 | In distribution | |
| 03.70.492 | In distribution | |
| 03.70.420 | In distribution | |
| 03.70.169 | In distribution | |
| 03.70.237 | In distribution | |
| 03.70.488 | In distribution | |
| 03.71.130 | In distribution | |
| 03.70.059 | In distribution | |
| 03.70.132 | In distribution | |
| 03.70.276 | In distribution | |
| 03.71.355 | In distribution | |
| 03.70.021 | In distribution | |
| 03.70.009 | In distribution | |
| 03.71.373 | In distribution | |
| 03.70.094 | In distribution | |
| 03.70.268 | In distribution | |
| 03.70.159 | In distribution | |
| 03.70.294 | In distribution | |
| 03.70.243 | In distribution | |
| 03.70.043 | In distribution | |
| 03.70.175 | In distribution | |
| 03.71.043 | In distribution | |
| 03.70.010 | In distribution | |
| 03.70.088 | In distribution | |
| 03.71.120 | In distribution | |
| 03.70.128 | In distribution | |
| 03.71.124 | In distribution | |
| 03.70.468 | In distribution | |
| 03.70.073 | In distribution | |
| 03.70.007 | In distribution | |
| 03.71.049 | In distribution | |
| 03.70.055 | In distribution | |
| 03.71.045 | In distribution | |
| 03.71.042 | In distribution | |
| 03.70.143 | In distribution | |
| 03.71.146 | In distribution | |
| 03.71.132 | In distribution | |
| 03.70.267 | In distribution | |
| 03.70.293 | In distribution | |
| 03.71.047 | In distribution | |
| 03.70.290 | In distribution | |
| 03.70.116 | In distribution | |
| 03.70.176 | In distribution | |
| 03.70.082 | In distribution | |
| 03.70.120 | In distribution | |
| 03.70.098 | In distribution | |
| 03.71.243 | In distribution | |
| 03.70.144 | In distribution | |
| 03.70.414 | In distribution | |
| 03.70.295 | In distribution | |
| 03.71.249 | In distribution | |
| 03.70.027 | In distribution | |
| 03.70.006 | In distribution | |
| 03.70.173 | In distribution | |
| 03.71.134 | In distribution | |
| 03.70.041 | In distribution | |
| 03.70.361 | In distribution | |
| 03.71.001 | In distribution | |
| 03.71.148 | In distribution | |
| 03.71.086 | In distribution | |
| 03.71.128 | In distribution | |
| 03.70.035 | In distribution | |
| 03.70.249 | In distribution |
Showing 250 of 286 catalogue numbers.
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 |
|---|---|
| K140361 | 2014-06-12 |
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.