Custom Spine, Inc.
Medical device manufacturer in Parsippany, NJ.
14510(k) clearances
0PMA approvals
1recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 5
- KWP Appliance, Fixation, Spinal Interlaminal 2
- NKB Thoracolumbosacral Pedicle Screw System 2
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- ODP Intervertebral Fusion Device With Bone… 1
- MRW System, Facet Screw Spinal Device 1
- OVD Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K143143 | Pathway ElifMAX · Traditional | 07/22/2015SE |
| K132596 | Proposed OptimusOVD · Traditional | 04/11/2014SE |
| K120597 | KompredaMRW · Traditional | 05/03/2013SE |
| K111726 | Pathway AvidMAX · Traditional | 02/06/2012SE |
| K111774 | Pathway Model 07XXXXMAX · Special | 07/20/2011SE |
| K111099 | Issys LP Spinal Fixation SystemNKB · Special | 05/05/2011SE |
| K101151 | Regent Anterior Cervical PlateKWQ · Special | 05/19/2010SE |
| K092904 | Pathway Ivb/VbrODP · Traditional | 12/22/2009SE |
| K091134 | Custom Spine Regent Anterior Cervical PlateKWQ · Traditional | 08/17/2009SE |
| K090566 | Pathway AvidMAX · Traditional | 06/01/2009SE |
| K080281 | PathwayMAX · Traditional | 05/01/2008SE |
| K072866 | Issys LP Spinal Fixation SystemKWP · Traditional | 12/13/2007SE |
| K070281 | Issys LP Spinal Fixation SystemNKB · Traditional | 06/11/2007SE |
| K043522 | Issys Pedicle Screw SystemKWP · Traditional | 01/14/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1819-2013 Class II | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx…On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out… | 03/28/2013Terminated |