Syntec Scientific Corp.
Medical device manufacturer in Chang Hua, TW.
19510(k) clearances
0PMA approvals
0recalls
Device types
- HSB Rod, Fixation, Intramedullary And Accessories 6
- HRS Plate, Fixation, Bone 3
- JDW Pin, Fixation, Threaded 2
- KTT Appliance, Fixation, Nail/Blade/Plate… 2
- OAT Implant, Endosseous, Orthodontic 2
- HTY Pin, Fixation, Smooth 1
- HWC Screw, Fixation, Bone 1
- NKB Thoracolumbosacral Pedicle Screw System 1
- DZE Implant, Endosseous, Root-Form 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K202790 | Syntec Orthodontic Mini Screw Extended SystemOAT · Special | 09/17/2021SE |
| K202935 | Syntec Femoral Nail Extended SystemHSB · Special | 10/28/2020SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | 05/05/2020SE |
| K191617 | Syntec Tibial Nail SystemHSB · Traditional | 09/03/2019SE |
| K181296 | Syntec Femoral Nail SystemHSB · Traditional | 04/11/2019SE |
| K161327 | Syntec Humeral Nail SystemHSB · Traditional | 06/08/2017SE |
| K111189 | Syntec Dental ImplantDZE · Traditional | 12/20/2012SE |
| K101971 | Syntec Os Spinal Fixation SystemNKB · Traditional | 03/25/2011SE |
| K092889 | Syntec Osteo-Plate and Screw FixationHRS · Traditional | 06/25/2010SE |
| K090476 | Syntec Orthodontic Mini ScrewOAT · Traditional | 06/18/2009SE |
| K090839 | Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsHRS · Special | 04/24/2009SE |
| K984602 | Syntec-Taichung Non-Sterile Unreamed Interlocking Nail SystemHSB · Traditional | 03/05/1999SE |
| K984364 | Syntec-Taichung Non-Sterile Small Orthopedic Fixation System, Model 71100, 294-300,400 &…KTT · Traditional | 03/02/1999SE |
| K984543 | Syntec-Taichung Non-Sterile Interlocking Nail System, MODEL:HUMERUS:256-000/280…HSB · Traditional | 03/01/1999SE |
| K983988 | Syntec-Taichung Non-Sterile Titanium Alloy Mini-PlateHRS · Traditional | 01/27/1999SE |
| K983873 | Syntec-Taichung Non-Sterile Dhs/Dcs Plate SystemKTT · Traditional | 12/30/1998SE |
| K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'s 222020-248120…HWC · Traditional | 12/16/1998SE |
| K983757 | Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar:…JDW · Traditional | 12/04/1998SE |
| K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…HTY · Traditional | 10/05/1998SE |