Pro-Fix™ Precision Fixation System
1.5 mm x 10.0 mm self-drilling fully threaded titanium alloy tenting screw
3manufacturers in China registered for this device type
24catalogue numbers in this listing
1510(k) clearance
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 | Osteogenics Biomedical, Inc., United States |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K093719 |
| Record published | 2022-11-29 |
| 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, manufacturing date |
| Sizes | Length 3 to 14 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PFMK20 | In distribution | ||
| PFB12 | Length 12.0 mm | In distribution | |
| PFT10-5 | Length 10.0 mm | 5 | In distribution |
| PFB10-5 | Length 10.0 mm | 5 | In distribution |
| PFT3-5 | Length 3.0 mm | 5 | In distribution |
| PFT5 | Length 5.0 mm | In distribution | |
| PFMF5-5 | Length 5.0 mm | 5 | In distribution |
| PFT5-5 | Length 5.0 mm | 5 | In distribution |
| PFT10 | Length 10.0 mm | In distribution | |
| PFT4 | Length 4.0 mm | In distribution | |
| PFBK12 | In distribution | ||
| PFB10 | Length 10.0 mm | In distribution | |
| PFT8-5 | Length 8.0 mm | 5 | In distribution |
| PFT8 | Length 8.0 mm | In distribution | |
| PFT4-5 | Length 4.0 mm | 5 | In distribution |
| PFT3 | Length 3.0 mm | In distribution | |
| PFB14 | Length 14.0 mm | In distribution | |
| PFMF-5 | Length 3.0 mm | 5 | In distribution |
| PFTK12 | In distribution | ||
| PFB8 | Length 8.0 mm | In distribution | |
| PFTK10 | In distribution | ||
| PFB12-5 | Length 12.0 mm | 5 | In distribution |
| PFB14-5 | Length 14.0 mm | 5 | In distribution |
| PFB8-5 | Length 8.0 mm | 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 |
| 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 |
Showing 12 of 92. All products under Screw, Fixation, Intraosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093719 | 2010-03-01 |
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.