Spine Wave, Inc.
Medical device manufacturer in Shelton, CT.
59510(k) clearances
0PMA approvals
3recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 14
- MNI Orthosis, Spinal Pedicle Fixation 11
- MQP Spinal Vertebral Body Replacement Device 10
- NKB Thoracolumbosacral Pedicle Screw System 7
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- NKG Posterior Cervical Screw System 3
- OLO Orthopedic Stereotaxic Instrument 3
- OVE Intervertebral Fusion Device With… 2
- HRS Plate, Fixation, Bone 1
- NDN Cement, Bone, Vertebroplasty 1
- OBL Cement, Bone, Pre-Formed, Modular… 1
- MRW System, Facet Screw Spinal Device 1
- OVD Intervertebral Fusion Device With… 1
- PML Bone Cement, Posterior Screw Augmentation 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | 05/29/2026SE |
| K243816 | Testa TP Pivoting Spacer SystemMAX · Traditional | 06/27/2025SE |
| K251131 | Annex® 2 Adjacent Level SystemNKB · Traditional | 06/06/2025SE |
| K243514 | Salvo® Robotic Navigation InstrumentsOLO · Traditional | 04/03/2025SE |
| K240685 | Salvo® Spine SystemNKB · Traditional | 05/06/2024SE |
| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | 07/25/2023SE |
| K222362 | Salvo® Spine SystemNKB · Special | 08/29/2022SE |
| K202476 | Salvo® Spine SystemNKB · Traditional | 11/05/2020SE |
| K192526 | Spine Wave Navigated InstrumentsOLO · Special | 10/10/2019SE |
| K191045 | Salvo Spine SystemNKB · Traditional | 07/10/2019SE |
| K182954 | Salvo Spine SystemNKB · Traditional | 12/12/2018SE |
| K181596 | Spine Wave Navigated InstrumentsOLO · Traditional | 10/24/2018SE |
| K181440 | Proficient® Posterior Cervical Spine SystemNKG · Special | 07/30/2018SE |
| K172594 | Proficient® Posterior Cervical Spine SystemNKG · Traditional | 12/15/2017SE |
| K173175 | Paramount Anterior Cervical Cage SystemOVE · Special | 11/01/2017SE |
| K172175 | CapSure® PS SystemNKB · Special | 08/16/2017SE |
| K163246 | Leva Anterior Expandable Spacer SystemMAX · Traditional | 04/06/2017SE |
| K162760 | Spine Wave Anterior Cervical Spine SystemOVE · Traditional | 02/16/2017SE |
| K162639 | Proficient Posterior Cervical Spine SystemNKG · Traditional | 02/07/2017SE |
| K161993 | Leva® Anterior Interbody SystemOVD · Traditional | 11/22/2016SE |
| K153222 | Leva Spacer SystemMAX · Traditional | 04/15/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | 02/26/2016SE |
| K152620 | Spine Wave Gen II Expandable Interbody SystemMAX · Traditional | 01/15/2016SE |
| K152174 | Sniper Spine SystemMNI · Special | 08/31/2015SE |
| K151813 | Sniper Spine SystemMNI · Special | 07/31/2015SE |
| K151581 | Leva Spacer SystemMAX · Special | 07/09/2015SE |
| K150285 | Leva(TM) Spacer SystemMAX · Special | 03/05/2015SE |
| K142996 | StaXx(R) XD SystemMQP · Traditional | 02/19/2015SE |
| K141980 | Leva (TM) Spacer SystemMAX · Traditional | 01/26/2015SE |
| K142980 | Proficient (TM) Facet Screw Spine SystemMRW · Traditional | 01/16/2015SE |
| K142101 | Abacus (TM) Spacer SystemMAX · Traditional | 10/23/2014SE |
| K140007 | Abacus TM Spacer SystemMAX · Traditional | 04/07/2014SE |
| K132403 | Annextm Adjacent Level SystemMNH · Traditional | 01/10/2014SE |
| K133207 | Staxx(R) SystemMQP · Special | 12/06/2013SE |
| K132719 | Staxx Ibl SystemMAX · Special | 10/04/2013SE |
| K131071 | Staxx Ibl SystemMAX · Traditional | 08/20/2013SE |
| K132154 | Capsure PS SystemMNI · Special | 08/09/2013SE |
| K123461 | Staxx(R) Ib SystemMAX · Traditional | 04/11/2013SE |
| K122233 | Capsure(R) PS SystemMNI · Special | 10/11/2012SE |
| K121889 | Staxx XD SystemMQP · Special | 08/29/2012SE |
| K120646 | Capsure(R) PS SystemMNI · Traditional | 06/07/2012SE |
| K111418 | Staxx(R) XD SystemMQP · Traditional | 12/13/2011SE |
| K111913 | Capsure(R) PS SystemMNI · Special | 08/31/2011SE |
| K102315 | Staxx XDL SystemMQP · Traditional | 08/19/2011SE |
| K111469 | Staxxsd SystemMQP · Special | 07/19/2011SE |
| K102682 | Staxx(R) XD SystemMQP · Special | 11/30/2010SE |
| K101288 | Staxx XD SystemMQP · Traditional | 09/10/2010SE |
| K100605 | Mis SystemMNH · Traditional | 06/04/2010SE |
| K100122 | Modification to Capsure PS SystemMNH · Special | 02/12/2010SE |
| K090315 | Staxx XD SystemMQP · Traditional | 09/03/2009SE |
| K083743 | Capsure PS SystemMNI · Special | 01/13/2009SE |
| K083353 | Capsure(R) PS SystemMNI · Special | 12/11/2008SE |
| K081228 | Capsure PS (R) Spine SystemMNI · Special | 05/12/2008SE |
| K063606 | Modification to Staxx FX SystemOBL · Traditional | 04/13/2007SE |
| K070245 | Capsure Pedicle Screw SystemMNI · Traditional | 04/05/2007SE |
| K053336 | Staxx FX SystemNDN · Traditional | 07/03/2006SE |
| K052670 | Staxx XD SystemMQP · Traditional | 04/27/2006SE |
| K033303 | Wafer SystemHRS · Traditional | 06/24/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1960-2015 Class II | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink…Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm | 05/04/2015Terminated |
| Z-2187-2013 Class II | StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device…A component Superior endplate manufactured from a different polymer than specified | 05/14/2013Terminated |
| Z-0967-2011 | StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H)…Package Insert Incorrect | 10/22/2010Terminated |