Endius, Inc.
Medical device manufacturer in Plainville, MA.
33510(k) clearances
0PMA approvals
0recalls
Device types
- HRX Arthroscope 9
- NKB Thoracolumbosacral Pedicle Screw System 7
- MNI Orthosis, Spinal Pedicle Fixation 4
- KWP Appliance, Fixation, Spinal Interlaminal 4
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- GEI Electrosurgical, Cutting & Coagulation &… 2
- EOB Nasopharyngoscope (Flexible Or Rigid) 1
- GWG Endoscope, Neurological 1
- OCX Endoscopic Irrigation/Suction System 1
- KWQ Appliance, Fixation, Spinal Intervertebral… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K080258 | Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 03/10/2008SE |
| K073510 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 02/11/2008SE |
| K073267 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 01/30/2008SE |
| K072840 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 12/07/2007SE |
| K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 09/06/2007SE |
| K070367 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 04/12/2007SE |
| K061345 | Modification to Endius Atavi SystemHRX · Special | 06/06/2006SE |
| K060990 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 04/26/2006SE |
| K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemKWP · Traditional | 04/18/2006SE |
| K053267 | Endius Atavi SystemHRX · Traditional | 01/13/2006SE |
| K041808 | Endius Title 2 Polyaxial Spinal SystemKWP · Special | 10/01/2004SE |
| K022199 | Endius Atavi SystemHRX · Traditional | 10/02/2002SE |
| K022578 | Endius Flextip BladeHRX · Special | 08/23/2002SE |
| K021881 | Endius Title Spinal Fixation SystemMNH · Traditional | 07/29/2002SE |
| K021748 | Endius Atavi SystemHRX · Special | 06/26/2002SE |
| K014090 | Endius Spinal Fixation SystemKWP · Traditional | 03/11/2002SE |
| K014107 | Endius Cervical Plate SystemKWQ · Traditional | 02/13/2002SE |
| K013403 | Tri-Fix Spinal Fixation SystemMNI · Special | 11/14/2001SE |
| K012488 | Modification To:Endius Bipolar SheathGEI · Special | 08/30/2001SE |
| K011830 | Tri-Fix Spinal Fixation SystemKWP · Traditional | 07/23/2001SE |
| K010922 | Tri-Fix Spinal Fixation SystemMNI · Traditional | 06/06/2001SE |
| K010903 | Tri-Fix Spinal Fixation SystemMNI · Traditional | 06/06/2001SE |
| K003897 | Endius Bipolar SheathGEI · Traditional | 03/22/2001SE |
| K010535 | Trifix Spinal Fixation SystemMNH · Special | 03/19/2001SE |
| K002437 | Endius Endoscopic Access SystemHRX · Traditional | 10/02/2000SE |
| K001627 | Trifix Spinal Fixation SystemMNH · Special | 06/03/2000SE |
| K000766 | Tri-Fix Spinal Fixation SystemMNI · Traditional | 06/01/2000SE |
| K994425 | Modification to Endoscopic Spinal Access SystemHRX · Traditional | 02/16/2000SE |
| K992535 | Endius Suction/Irrigation InstrumentOCX · Traditional | 09/01/1999SE |
| K991794 | Endoscopic Spinal Access SystemHRX · Traditional | 08/13/1999SE |
| K983144 | Flexposure RetractorHRX · Traditional | 02/24/1999SE |
| K982819 | Endius Spine EndoscopeGWG · Traditional | 01/27/1999SE |
| K972450 | Flextip GrasperEOB · Traditional | 11/21/1997SE |