Company ยท TW
Syntec Scientific Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2021. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 |
| HRS | Plate, Fixation, Bone | 3 |
| JDW | Pin, Fixation, Threaded | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| OAT | Implant, Endosseous, Orthodontic | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2021 | K202790 | Syntec Orthodontic Mini Screw Extended System Syntec Scientific Corporation, TW | OAT |
| Oct 28, 2020 | K202935 | Syntec Femoral Nail Extended System Syntec Scientific Corporation, TW | HSB |
| May 5, 2020 | K200933 | Syntec Non-Sterile Steinmann Pins System Syntec Scientific Corporation, TW | JDW |
| Sep 3, 2019 | K191617 | Syntec Tibial Nail System Syntec Scientific Corporation, TW | HSB |
| Apr 11, 2019 | K181296 | Syntec Femoral Nail System Syntec Scientific Corporation, TW | HSB |
| Jun 8, 2017 | K161327 | SYNTEC HUMERAL NAIL SYSTEM Syntec Scientific Corporation, TW | HSB |
| Dec 20, 2012 | K111189 | SYNTEC DENTAL IMPLANT Syntec Scientific Corp., TW | DZE |
| Mar 25, 2011 | K101971 | SYNTEC OS SPINAL FIXATION SYSTEM Syntec Scientific Corp., TW | NKB |
| Jun 25, 2010 | K092889 | SYNTEC OSTEO-PLATE AND SCREW FIXATION Syntec Scientific Corp., TW | HRS |
| Jun 18, 2009 | K090476 | SYNTEC ORTHODONTIC MINI SCREW Syntec Scientific Corp., TW | OAT |
| Apr 24, 2009 | K090839 | MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS Syntec Scientific Corp., TW | HRS |
| Mar 5, 1999 | K984602 | SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM Syntec Scientific Corp., TW | HSB |
| Mar 2, 1999 | K984364 | SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 Syntec Scientific Corp., TW | KTT |
| Mar 1, 1999 | K984543 | SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 Syntec Scientific Corp., TW | HSB |
| Jan 27, 1999 | K983988 | SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE Syntec Scientific Corp., TW | HRS |
| Dec 30, 1998 | K983873 | SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM Syntec Scientific Corp., TW | KTT |
| Dec 16, 1998 | K983495 | SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 Syntec Scientific Corp., TW | HWC |
| Dec 4, 1998 | K983757 | SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 Syntec Scientific Corp., TW | JDW |
| Oct 5, 1998 | K983121 | NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 Syntec Scientific Corp., TW | HTY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||