Lanx, Inc.
Medical device manufacturer in Broomfield, CO.
36510(k) clearances
0PMA approvals
1recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 9
- KWP Appliance, Fixation, Spinal Interlaminal 7
- KWQ Appliance, Fixation, Spinal Intervertebral… 5
- MAX Intervertebral Fusion Device With Bone… 4
- MNI Orthosis, Spinal Pedicle Fixation 3
- OVD Intervertebral Fusion Device With… 3
- MQP Spinal Vertebral Body Replacement Device 1
- MNH Orthosis, Spondylolisthesis Spinal Fixation 1
- MRW System, Facet Screw Spinal Device 1
- ODP Intervertebral Fusion Device With Bone… 1
- OVE Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K131547 | Lanx Fusion SystemOVD · Special | 07/12/2013SE |
| K131156 | Lanx Spinal Fixation SystemKWP · Special | 05/24/2013SE |
| K123767 | Lanx Fusion System- SAOVD · Traditional | 03/18/2013SE |
| K121316 | Lanx Spinal Fization SystemNKB · Traditional | 09/10/2012SE |
| K122145 | Lanx Spinal Fixation SystemNKB · Special | 08/17/2012SE |
| K121940 | Lanx Spinal Fixation SystemNKB · Special | 08/02/2012SE |
| K120399 | Lanx Spinal Fixation SystemNKB · Special | 03/09/2012SE |
| K113434 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)NKB · Special | 12/19/2011SE |
| K112388 | Lanx Cervical SAOVE · Traditional | 12/16/2011SE |
| K103091 | Lanx Spinal Fixation SystemKWP · Special | 04/15/2011SE |
| K103237 | Lanx Spinal SystemNKB · Special | 03/25/2011SE |
| K103666 | Lanx LateralMAX · Traditional | 03/23/2011SE |
| K103660 | Lanx Cervical Intervertebral Body Fusion SystemODP · Special | 02/28/2011SE |
| K102738 | Lanx Fusion SystemOVD · Traditional | 02/10/2011SE |
| K103040 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)NKB · Special | 02/08/2011SE |
| K100888 | Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemKWP · Special | 11/15/2010SE |
| K101364 | Lanx Facet Screw SystemMRW · Traditional | 08/16/2010SE |
| K100935 | Lanx Spinal Fixation SystemNKB · Special | 08/06/2010SE |
| K100191 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)KWP · Special | 04/15/2010SE |
| K092765 | Lanx Anterior Plating SystemKWQ · Traditional | 04/07/2010SE |
| K093285 | Modification to Lanx Spinal Fixation SystemMNI · Special | 12/10/2009SE |
| K092656 | Lanx Posterior Cervicothoracic Spinal Fixation SystemKWP · Traditional | 11/24/2009SE |
| K092536 | Spinal Fixation SystemNKB · Traditional | 10/30/2009SE |
| K083815 | Lanx Fusion SystemMAX · Traditional | 04/20/2009SE |
| K090316 | Modification to: Lanx Anterior Cervical Plate SystemKWQ · Special | 04/07/2009SE |
| K083581 | Lanx Spinal Fixation SystemMNH · Special | 04/07/2009SE |
| K090252 | Modification to: Lanx Spinal Fixation SystemKWP · Special | 03/04/2009SE |
| K082774 | Lanx Cervical Intervertebral Body Fusion DeviceMAX · Traditional | 10/21/2008SE |
| K073144 | Lanx Intervertebral Body Fusion DeviceMAX · Traditional | 01/24/2008SE |
| K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS)KWQ · Traditional | 12/28/2007SE |
| K071877 | Lanx Spinal Fixation SystemMNI · Traditional | 09/17/2007SE |
| K071633 | Lanx Deformity SystemKWP · Special | 08/15/2007SE |
| K052384 | Lanx VBR SystemMQP · Traditional | 10/07/2005SE |
| K043484 | Lanx Spinal Fixation SystemMNI · Abbreviated | 05/16/2005SE |
| K050774 | Lanx Anterior Cervical Plate SystemKWQ · Special | 04/11/2005SE |
| K040401 | Lanx Anterior Cervial Plate SystemKWQ · Traditional | 04/12/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0400-2014 Class II | LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver -…Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because… | 11/04/2013Terminated |