O'Tec Corp.
Medical device manufacturer in Ellis, KS.
23510(k) clearances
0PMA approvals
0recalls
Device types
- KTT Appliance, Fixation, Nail/Blade/Plate… 4
- JDW Pin, Fixation, Threaded 3
- HTY Pin, Fixation, Smooth 3
- JDR Staple, Fixation, Bone 3
- HWC Screw, Fixation, Bone 3
- IOR Wheelchair, Mechanical 2
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 2
- KTW Appliance, Fixation, Nail/Blade/Plate… 1
- HRS Plate, Fixation, Bone 1
- JDI Prosthesis, Hip, Semi-Constrained… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K943293 | SCC22/ SCC26 Shower Commode ChairIOR · Traditional | 08/19/1994SE |
| K910093 | Futura Femoral Hip StemJDI · Traditional | 07/01/1991SE |
| K905358 | Cancellous ScrewHWC · Traditional | 01/04/1991SN |
| K905357 | Cortical Bone Screw (European Style)HWC · Traditional | 01/04/1991SN |
| K905355 | Broad Self-Compressing PlateHRS · Traditional | 01/04/1991SN |
| K905347 | Hagie PinJDW · Traditional | 01/04/1991SN |
| K905333 | U.S. Type Cruciate Slot Bone ScrewHWC · Traditional | 01/04/1991SN |
| K905364 | Round StapleJDR · Traditional | 12/11/1990SE |
| K905363 | Fixation StapleJDR · Traditional | 12/11/1990SE |
| K905362 | Barbed Square StapleJDR · Traditional | 12/11/1990SE |
| K905352 | Blade PlateKTT · Traditional | 12/11/1990SE |
| K905349 | Austin Moore Type Hip ProthesisKWL · Traditional | 12/11/1990SE |
| K905348 | Hansen-Street Type Intramedullary NailKTW · Traditional | 12/11/1990SE |
| K905346 | Jewett Hip NailKTT · Traditional | 12/11/1990SE |
| K905345 | K-WireHTY · Traditional | 12/11/1990SE |
| K905344 | Knowles PinJDW · Traditional | 12/11/1990SE |
| K905342 | Lag ScrewKTT · Traditional | 12/11/1990SE |
| K905341 | Rush PinHTY · Traditional | 12/11/1990SE |
| K905338 | Side PlateKTT · Traditional | 12/11/1990SE |
| K905337 | Steinman PinHTY · Traditional | 12/11/1990SE |
| K905336 | Steinman Pin, ThreadedJDW · Traditional | 12/11/1990SE |
| K905334 | Thompson Type Hip ProsthesisKWL · Traditional | 12/11/1990SE |
| K883034 | Wheelchair BCW 6000IOR · Traditional | 08/02/1988SE |