CMF Visionare
Emergency Self-Tapping Screw D 1.8mm, 16mm
3manufacturers in China registered for this device type
155catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Dentalmaster (Xiamen) Medical Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Visionare LLC, United States |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180204 |
| Record published | 2019-02-21 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1.900.244 | 5 | In distribution | |
| 1.900.154 | 5 | In distribution | |
| 1.900.232 | 5 | In distribution | |
| 1.900.221 | 5 | In distribution | |
| 1.900.153 | 5 | In distribution | |
| 1.900.302 | 5 | In distribution | |
| 1.900.169 | 5 | In distribution | |
| 1.900.208 | 5 | In distribution | |
| 1.900.155 | 5 | In distribution | |
| 1.900.215 | 5 | In distribution | |
| 1.900.193 | 5 | In distribution | |
| 1.900.324 | 5 | In distribution | |
| 1.908.009 | In distribution | ||
| 1.900.222 | 5 | In distribution | |
| 1.900.203 | 5 | In distribution | |
| 1.900.246 | 5 | In distribution | |
| 1.900.165 | 5 | In distribution | |
| 1.900.182 | 5 | In distribution | |
| 1.900.330 | 5 | In distribution | |
| 1.900.306 | 5 | In distribution | |
| 1.900.188 | 5 | In distribution | |
| 1.900.104 | 5 | In distribution | |
| 1.900.162 | 5 | In distribution | |
| 1.900.103 | 5 | In distribution | |
| 1.900.187 | 5 | In distribution | |
| 1.900.229 | 5 | In distribution | |
| 1.900.240 | 5 | In distribution | |
| 1.900.142 | 5 | In distribution | |
| 1.908.001 | In distribution | ||
| 1.900.160 | 5 | In distribution | |
| 1.900.242 | 5 | In distribution | |
| 1.900.231 | 5 | In distribution | |
| 1.900.211 | 5 | In distribution | |
| 1.900.307 | 5 | In distribution | |
| 1.900.168 | 5 | In distribution | |
| 1.900.326 | 5 | In distribution | |
| 1.900.325 | 5 | In distribution | |
| 1.900.133 | 5 | In distribution | |
| 1.900.170 | 5 | In distribution | |
| 1.908.023 | In distribution | ||
| 1.900.112 | 5 | In distribution | |
| 1.900.130 | 5 | In distribution | |
| 1.900.228 | 5 | In distribution | |
| 1.900.190 | 5 | In distribution | |
| 1.900.184 | 5 | In distribution | |
| 1.900.181 | 5 | In distribution | |
| 1.900.206 | 5 | In distribution | |
| 1.908.028 | In distribution | ||
| 1.908.010 | In distribution | ||
| 1.900.110 | 5 | In distribution | |
| 1.900.329 | 5 | In distribution | |
| 1.900.139 | 5 | In distribution | |
| 1.900.166 | 5 | In distribution | |
| 1.900.117 | 5 | In distribution | |
| 1.900.173 | 5 | In distribution | |
| 1.900.245 | 5 | In distribution | |
| 1.900.194 | 5 | In distribution | |
| 1.900.241 | 5 | In distribution | |
| 1.900.309 | 5 | In distribution | |
| 1.900.115 | 5 | In distribution | |
| 1.900.114 | 5 | In distribution | |
| 1.900.105 | 5 | In distribution | |
| 1.900.204 | 5 | In distribution | |
| 1.900.224 | 5 | In distribution | |
| 1.900.304 | 5 | In distribution | |
| 1.900.201 | 5 | In distribution | |
| 1.900.113 | 5 | In distribution | |
| 1.900.311 | 5 | In distribution | |
| 1.900.172 | 5 | In distribution | |
| 1.908.029 | In distribution | ||
| 1.900.210 | 5 | In distribution | |
| 1.900.100 | 5 | In distribution | |
| 1.900.310 | 5 | In distribution | |
| 1.900.164 | 5 | In distribution | |
| 1.900.150 | 5 | In distribution | |
| 1.900.180 | 5 | In distribution | |
| 1.900.175 | 5 | In distribution | |
| 1.900.111 | 5 | In distribution | |
| 1.900.223 | 5 | In distribution | |
| 1.900.189 | 5 | In distribution | |
| 1.900.214 | 5 | In distribution | |
| 1.900.301 | 5 | In distribution | |
| 1.900.171 | 5 | In distribution | |
| 1.900.328 | 5 | In distribution | |
| 1.900.132 | 5 | In distribution | |
| 1.900.226 | 5 | In distribution | |
| 1.900.209 | 5 | In distribution | |
| 1.900.186 | 5 | In distribution | |
| 1.900.119 | 5 | In distribution | |
| 1.908.002 | In distribution | ||
| 1.908.024 | In distribution | ||
| 1.908.022 | In distribution | ||
| 1.900.191 | 5 | In distribution | |
| 1.900.323 | 5 | In distribution | |
| 1.908.008 | In distribution | ||
| 1.900.305 | 5 | In distribution | |
| 1.900.250 | 5 | In distribution | |
| 1.900.249 | 5 | In distribution | |
| 1.900.227 | 5 | In distribution | |
| 1.900.243 | 5 | In distribution | |
| 1.900.134 | 5 | In distribution | |
| 1.900.101 | 5 | In distribution | |
| 1.900.116 | 5 | In distribution | |
| 1.908.021 | In distribution | ||
| 1.908.020 | In distribution | ||
| 1.900.200 | 5 | In distribution | |
| 1.900.118 | 5 | In distribution | |
| 1.908.026 | In distribution | ||
| 1.900.138 | 5 | In distribution | |
| 1.900.121 | 5 | In distribution | |
| 1.900.207 | 5 | In distribution | |
| 1.900.122 | 5 | In distribution | |
| 1.900.141 | 5 | In distribution | |
| 1.900.152 | 5 | In distribution | |
| 1.908.025 | In distribution | ||
| 1.900.136 | 5 | In distribution | |
| 1.900.135 | 5 | In distribution | |
| 1.900.320 | 5 | In distribution | |
| 1.900.303 | 5 | In distribution | |
| 1.900.140 | 5 | In distribution | |
| 1.900.131 | 5 | In distribution | |
| 1.908.005 | In distribution | ||
| 1.900.213 | 5 | In distribution | |
| 1.900.308 | 5 | In distribution | |
| 1.900.167 | 5 | In distribution | |
| 1.900.248 | 5 | In distribution | |
| 1.908.003 | In distribution | ||
| 1.900.137 | 5 | In distribution | |
| 1.900.202 | 5 | In distribution | |
| 1.900.151 | 5 | In distribution | |
| 1.900.220 | 5 | In distribution | |
| 1.900.183 | 5 | In distribution | |
| 1.900.300 | 5 | In distribution | |
| 1.900.185 | 5 | In distribution | |
| 1.900.225 | 5 | In distribution | |
| 1.900.205 | 5 | In distribution | |
| 1.900.212 | 5 | In distribution | |
| 1.900.161 | 5 | In distribution | |
| 1.900.156 | 5 | In distribution | |
| 1.900.247 | 5 | In distribution | |
| 1.900.163 | 5 | In distribution | |
| 1.900.260 | 5 | In distribution | |
| 1.900.322 | 5 | In distribution | |
| 1.908.027 | In distribution | ||
| 1.900.230 | 5 | In distribution | |
| 1.900.321 | 5 | In distribution | |
| 1.908.004 | In distribution | ||
| 1.900.174 | 5 | In distribution | |
| 1.900.327 | 5 | In distribution | |
| 1.900.312 | 5 | In distribution | |
| 1.900.120 | 5 | In distribution | |
| 1.908.006 | In distribution | ||
| 1.900.192 | 5 | In distribution | |
| 1.908.007 | In distribution | ||
| 1.900.102 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 1,295 |
| Faico CMF System | Faico Medical, LLC | 540 |
| Neoface | Neoortho Produtos Ortopédicos S/A | 181 |
| Universal Mandible AXS | Stryker Leibinger Gmbh & Co. KG | 148 |
| Tandry CMF Plate System | Microware Precision Co., Ltd. | 140 |
| Screw, Fixation, Intraosseous | Synthes Gmbh | 132 |
| Level ONE CMF | KLS-Martin L.P. | 71 |
| MatrixMIDFACE | Synthes Gmbh | 65 |
| PlusDrive | Synthes Gmbh | 52 |
| Universal 2.0 MP AXS | Stryker Leibinger Gmbh & Co. KG | 51 |
| MCI – Medical Concept Innovation, Inc. | MCI Medical Concept Innovation Inc. | 49 |
| CMF | Southern Medical (PTY) Ltd | 37 |
Showing 12 of 92. All products under Screw, Fixation, Intraosseous
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.