Spinal Concepts, Inc.
Medical device manufacturer in Austin, TX.
33510(k) clearances
0PMA approvals
0recalls
Device types
- KWP Appliance, Fixation, Spinal Interlaminal 5
- MNI Orthosis, Spinal Pedicle Fixation 5
- KWQ Appliance, Fixation, Spinal Intervertebral… 5
- JDK Prosthesis, Hip, Cement Restrictor 5
- MQP Spinal Vertebral Body Replacement Device 5
- MNH Orthosis, Spondylolisthesis Spinal Fixation 2
- NKB Thoracolumbosacral Pedicle Screw System 2
- HWC Screw, Fixation, Bone 1
- JDQ Cerclage, Fixation 1
- HRS Plate, Fixation, Bone 1
- GZT Retractor, Self-Retaining, For Neurosurgery 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K051000 | Fortitude Vue Vertebral Body Replacement DeviceMQP · Special | 05/19/2005SE |
| K050706 | Harmony Port System, Model 1907 SeriesGZT · Traditional | 04/15/2005SE |
| K040096 | Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional | 07/01/2004SE |
| K033663 | Spinal Concepts Inc. CodaMQP · Traditional | 05/27/2004SE |
| K033517 | Spinal Concepts Inc. Cadence and TraxisMQP · Special | 02/18/2004SE |
| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
| K031837 | Modification to Fortitude Cement RestrictorJDK · Special | 07/24/2003SE |
| K030087 | Spinal Concepts, Inc. Bacfix Ti Spinal SystemNKB · Abbreviated | 07/17/2003SE |
| K031914 | Spinal Concepts, Inc. Cadence and FortitudeMQP · Traditional | 07/12/2003SE |
| K030625 | Spinal Concepts Inc. PathfinderNKB · Special | 03/28/2003SE |
| K024326 | Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemKWQ · Special | 01/23/2003SE |
| K023647 | Cadence PEEK Cemeent RestrictorJDK · Special | 11/27/2002SE |
| K023644 | Modification to Incompass Spinal Fixation SystemMNI · Special | 11/25/2002SE |
| K021564 | Incompass Spinal Fixation SystemKWQ · Traditional | 10/25/2002SE |
| K021719 | Fortitude Cement RestrictorJDK · Traditional | 08/15/2002SESU |
| K022218 | Cadence Cement RestrictorJDK · Traditional | 08/12/2002SE |
| K021009 | Octafix Occipital Cervical Plating SystemKWP · Traditional | 06/18/2002SE |
| K020611 | Universal Bone Plate III System (Ubp III)HRS · Special | 03/27/2002SE |
| K013979 | Sc-Acufix Thinline Anterior Cervical Plate SystemKWQ · Special | 02/13/2002SE |
| K013887 | Bacfix Spinal Fixation SystemMNH · Traditional | 02/12/2002SE |
| K010563 | End-To-End and Side-By-Side ConnectorsMNI · Traditional | 05/25/2001SE |
| K003351 | Parsfix Cable-Screw SystemKWP · Traditional | 01/24/2001SE |
| K002082 | Speedlink Transverse ConnectorKWP · Traditional | 10/06/2000SE |
| K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemKWQ · Traditional | 02/12/1999SE |
| K983260 | Modification to Spinal Concepts Bacfix Ti Spinal Fixation SystemMNI · Traditional | 10/21/1998SE |
| K983258 | Modification to Spinal Concepts Bacfix Spinal Fixation SystemMNI · Traditional | 10/21/1998SE |
| K973687 | Spinal Concepts, Inc., Bacfix Ti Spinal Fixation SystemMNH · Traditional | 03/18/1998SN |
| K974020 | Spinal Concepts, Inc., Cfix Cable SystemJDQ · Traditional | 12/19/1997SE |
| K973586 | Spinal Concepts, Inc., Universal Bone Plate System IIHWC · Traditional | 11/07/1997SN |
| K964404 | Bacfix Spinal Fixation SystemKWP · Traditional | 03/26/1997SN |