Neoface
Emergency Self Tapping Screw SH Ø 1.8x 3.5 mm
3manufacturers in China registered for this device type
181catalogue 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 | Neoortho Produtos Ortopédicos S/A, Brazil |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| 510(k) | K102641 |
| Record published | 2015-10-08 |
| Record revised | 2024-06-19 (version 5) |
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, expiry date, manufacturing date |
| Distribution end date | 2017-12-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 924.007 | In distribution | |
| 923.009 | In distribution | |
| 923.100 | In distribution | |
| 925.124 | In distribution | |
| 924.025 | In distribution | |
| 925.027 | In distribution | |
| 925.048 | In distribution | |
| 925.046 | In distribution | |
| 924.501 | In distribution | |
| 924.340 | In distribution | |
| 924.031 | In distribution | |
| 923.110 | In distribution | |
| 925.052 | In distribution | |
| 924.309 | In distribution | |
| 924.331 | In distribution | |
| 925.101 | In distribution | |
| 923.121 | In distribution | |
| 924.406 | In distribution | |
| 924.013 | In distribution | |
| 924.330 | In distribution | |
| 924.323 | In distribution | |
| 924.009 | In distribution | |
| 924.302 | In distribution | |
| 923.124 | In distribution | |
| 923.015 | In distribution | |
| 924.034 | In distribution | |
| 924.327 | In distribution | |
| 924.400 | In distribution | |
| 925.055 | In distribution | |
| 923.106 | In distribution | |
| 924.403 | In distribution | |
| 924.410 | In distribution | |
| 925.200 | In distribution | |
| 925.024 | In distribution | |
| 924.310 | In distribution | |
| 924.008 | In distribution | |
| 924.343 | In distribution | |
| 925.203 | In distribution | |
| 924.017 | In distribution | |
| 924.003 | In distribution | |
| 925.103 | In distribution | |
| 924.321 | In distribution | |
| 924.320 | In distribution | |
| 923.028 | In distribution | |
| 924.329 | In distribution | |
| 924.402 | In distribution | |
| 923.014 | In distribution | |
| 925.106 | In distribution | |
| 924.002 | In distribution | |
| 924.006 | In distribution | |
| 925.223 | In distribution | |
| 925.126 | In distribution | |
| 924.201 | In distribution | |
| 923.012 | In distribution | |
| 923.107 | In distribution | |
| 925.004 | In distribution | |
| 923.013 | In distribution | |
| 925.227 | In distribution | |
| 923.005 | In distribution | |
| 923.104 | In distribution | |
| 923.132 | In distribution | |
| 923.123 | In distribution | |
| 925.001 | In distribution | |
| 925.102 | In distribution | |
| 924.409 | In distribution | |
| 923.109 | In distribution | |
| 923.010 | In distribution | |
| 925.226 | In distribution | |
| 924.408 | In distribution | |
| 923.103 | In distribution | |
| 925.221 | In distribution | |
| 924.341 | In distribution | |
| 925.050 | In distribution | |
| 924.202 | In distribution | |
| 924.324 | In distribution | |
| 925.053 | In distribution | |
| 924.016 | In distribution | |
| 923.111 | In distribution | |
| 925.028 | In distribution | |
| 924.104 | In distribution | |
| 925.006 | In distribution | |
| 925.122 | In distribution | |
| 924.307 | In distribution | |
| 924.326 | In distribution | |
| 923.003 | In distribution | |
| 925.121 | In distribution | |
| 924.107 | In distribution | |
| 923.004 | In distribution | |
| 925.023 | In distribution | |
| 924.032 | In distribution | |
| 924.029 | In distribution | |
| 924.405 | In distribution | |
| 924.325 | In distribution | |
| 925.201 | In distribution | |
| 925.025 | In distribution | |
| 923.102 | In distribution | |
| 924.005 | In distribution | |
| 923.001 | In distribution | |
| 924.101 | In distribution | |
| 924.026 | In distribution | |
| 924.103 | In distribution | |
| 923.030 | In distribution | |
| 925.007 | In distribution | |
| 924.502 | In distribution | |
| 925.204 | In distribution | |
| 925.120 | In distribution | |
| 901.500 | In distribution | |
| 923.120 | In distribution | |
| 925.058 | In distribution | |
| 924.028 | In distribution | |
| 924.303 | In distribution | |
| 925.057 | In distribution | |
| 924.035 | In distribution | |
| 924.027 | In distribution | |
| 925.049 | In distribution | |
| 925.104 | In distribution | |
| 924.322 | In distribution | |
| 924.301 | In distribution | |
| 924.105 | In distribution | |
| 923.133 | In distribution | |
| 924.404 | In distribution | |
| 925.100 | In distribution | |
| 925.059 | In distribution | |
| 923.016 | In distribution | |
| 924.308 | In distribution | |
| 925.005 | In distribution | |
| 923.130 | In distribution | |
| 924.328 | In distribution | |
| 923.026 | In distribution | |
| 925.125 | In distribution | |
| 924.305 | In distribution | |
| 924.304 | In distribution | |
| 923.131 | In distribution | |
| 925.105 | In distribution | |
| 924.407 | In distribution | |
| 925.202 | In distribution | |
| 924.306 | In distribution | |
| 924.030 | In distribution | |
| 923.008 | In distribution | |
| 924.500 | In distribution | |
| 924.102 | In distribution | |
| 925.206 | In distribution | |
| 925.054 | In distribution | |
| 924.200 | In distribution | |
| 925.047 | In distribution | |
| 923.122 | In distribution | |
| 901.300 | In distribution | |
| 924.342 | In distribution | |
| 924.014 | In distribution | |
| 923.011 | In distribution | |
| 925.026 | In distribution | |
| 925.056 | In distribution | |
| 923.029 | In distribution | |
| 924.100 | In distribution | |
| 925.003 | In distribution | |
| 925.002 | In distribution | |
| 924.004 | In distribution | |
| 925.220 | In distribution | |
| 924.401 | In distribution | |
| 923.002 | In distribution | |
| 924.033 | In distribution | |
| 925.224 | In distribution | |
| 923.007 | In distribution | |
| 924.036 | In distribution | |
| 924.018 | In distribution | |
| 923.101 | In distribution | |
| 924.300 | In distribution | |
| 924.001 | In distribution | |
| 925.123 | In distribution | |
| 923.108 | In distribution | |
| 923.105 | In distribution | |
| 923.031 | In distribution | |
| 925.205 | In distribution | |
| 925.022 | In distribution | |
| 925.051 | In distribution | |
| 923.006 | In distribution | |
| 924.015 | In distribution | |
| 925.240 | In distribution | |
| 925.222 | In distribution | |
| 924.106 | In distribution | |
| 924.045 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 1,295 |
| Faico CMF System | Faico Medical, LLC | 540 |
| CMF Visionare | Visionare LLC | 155 |
| 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.