MCI – Medical Concept Innovation, Inc.
Auto Drive Screw N 1.5 X 5MM-TI-CROSS-DRIVE
3manufacturers in China registered for this device type
49catalogue 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 | MCI Medical Concept Innovation Inc., United States |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K182758 |
| Record published | 2022-10-31 |
| Record revised | 2025-06-09 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A01.01.0010 | In distribution | |
| A01.01.0046 | In distribution | |
| A01.01.0035 | In distribution | |
| A01.01.0506 | In distribution | |
| A01.01.0218 | In distribution | |
| A01.01.0055 | In distribution | |
| A01.01.0004 | In distribution | |
| A01.01.0059 | In distribution | |
| A01.01.0008 | In distribution | |
| A01.01.0050 | In distribution | |
| A01.02.0003 | In distribution | |
| A01.01.0023 | In distribution | |
| A01.01.0000 | In distribution | |
| A01.01.0001 | In distribution | |
| A01.01.0057 | In distribution | |
| A01.01.0019 | In distribution | |
| A01.01.0033 | In distribution | |
| A01.02.0001 | In distribution | |
| A01.01.0217 | In distribution | |
| A01.01.0208 | In distribution | |
| A01.01.0040 | In distribution | |
| A01.01.0067 | In distribution | |
| A01.01.0002 | In distribution | |
| A01.01.0042 | In distribution | |
| A01.01.0052 | In distribution | |
| A01.01.0258 | In distribution | |
| A01.01.0074 | In distribution | |
| A01.01.0206 | In distribution | |
| A01.01.0207 | In distribution | |
| A01.01.0025 | In distribution | |
| A01.01.0253 | In distribution | |
| A01.02.0004 | In distribution | |
| A01.02.0005 | In distribution | |
| A01.01.0011 | In distribution | |
| A01.01.0044 | In distribution | |
| A01.02.0002 | In distribution | |
| A01.01.0034 | In distribution | |
| A01.01.0216 | In distribution | |
| A01.01.0053 | In distribution | |
| A01.01.0048 | In distribution | |
| A01.02.0000 | In distribution | |
| A01.01.0036 | In distribution | |
| A01.01.0038 | In distribution | |
| A01.01.0021 | In distribution | |
| A01.01.0205 | In distribution | |
| A01.01.0252 | In distribution | |
| A01.01.0018 | In distribution | |
| A01.01.0006 | In distribution | |
| A01.01.0255 | 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 |
| 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 |
| 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.