Company · US
Spine Wave, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (2 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 15 |
| 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 Integrated Fixation, Cervical | 2 |
| ETN | Stimulator, Nerve | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| NDN | Cement, Bone, Vertebroplasty | 1 |
| OBL | Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2026 | K260286 | Dynamo Spinal Cement; Salvo® Spine System Spine Wave, Inc. | PML |
| May 29, 2026 | K261159 | Exceed® Biplanar Expandable Interbody System Spine Wave, Inc. | MAX |
| Jun 27, 2025 | K243816 | Testa TP Pivoting Spacer System Spine Wave, Inc. | MAX |
| Jun 6, 2025 | K251131 | Annex® 2 Adjacent Level System Spine Wave, Inc. | NKB |
| Apr 3, 2025 | K243514 | Salvo® Robotic Navigation Instruments Spine Wave, Inc. | OLO |
| May 6, 2024 | K240685 | Salvo® Spine System Spine Wave, Inc. | NKB |
| Jul 25, 2023 | K231275 | Exceed Biplanar Expandable Interbody System Spine Wave, Inc. | MAX |
| Aug 29, 2022 | K222362 | Salvo® Spine System Spine Wave, Inc. | NKB |
| Nov 5, 2020 | K202476 | Salvo® Spine System Spine Wave, Inc. | NKB |
| Oct 10, 2019 | K192526 | Spine Wave Navigated Instruments Spine Wave, Inc. | OLO |
| Jul 10, 2019 | K191045 | Salvo Spine System Spine Wave, Inc. | NKB |
| Dec 12, 2018 | K182954 | Salvo Spine System Spine Wave, Inc. | NKB |
| Oct 24, 2018 | K181596 | Spine Wave Navigated Instruments Spine Wave, Inc. | OLO |
| Jul 30, 2018 | K181440 | Proficient® Posterior Cervical Spine System Spine Wave, Inc. | NKG |
| Dec 15, 2017 | K172594 | Proficient® Posterior Cervical Spine System Spine Wave, Inc. | NKG |
| Nov 1, 2017 | K173175 | Paramount Anterior Cervical Cage System Spine Wave, Inc. | OVE |
| Aug 16, 2017 | K172175 | CapSure® PS System Spine Wave, Inc. | NKB |
| Apr 6, 2017 | K163246 | Leva Anterior Expandable Spacer System Spine Wave, Inc. | MAX |
| Feb 16, 2017 | K162760 | Spine Wave Anterior Cervical Spine System Spine Wave, Inc. | OVE |
| Feb 7, 2017 | K162639 | Proficient Posterior Cervical Spine System Spine Wave, Inc. | NKG |
| Nov 22, 2016 | K161993 | Leva® Anterior Interbody System Spine Wave, Inc. | OVD |
| Apr 15, 2016 | K153222 | Leva Spacer System Spine Wave, Inc. | MAX |
| Feb 26, 2016 | K160003 | Sniper (R) Spine System Spine Wave, Inc. | MNI |
| Jan 15, 2016 | K152620 | Spine Wave Gen II Expandable Interbody System Spine Wave, Inc. | MAX |
| Aug 31, 2015 | K152174 | Sniper Spine System Spine Wave, Inc. | MNI |
| Jul 31, 2015 | K151813 | Sniper Spine System Spine Wave, Inc. | MNI |
| Jul 9, 2015 | K151581 | Leva Spacer System Spine Wave, Inc. | MAX |
| Mar 5, 2015 | K150285 | Leva(TM) Spacer System Spine Wave, Inc. | MAX |
| Feb 19, 2015 | K142996 | StaXx(R) XD System Spine Wave, Inc. | MQP |
| Jan 26, 2015 | K141980 | LEVA (TM) SPACER SYSTEM Spine Wave, Inc. | MAX |
| Jan 16, 2015 | K142980 | Proficient (TM) Facet Screw Spine System Spine Wave, Inc. | MRW |
| Oct 23, 2014 | K142101 | ABACUS (TM) SPACER SYSTEM Spine Wave, Inc. | MAX |
| Apr 7, 2014 | K140007 | ABACUS TM SPACER SYSTEM Spine Wave, Inc. | MAX |
| Jan 10, 2014 | K132403 | ANNEXTM ADJACENT LEVEL SYSTEM Spine Wave, Inc. | MNH |
| Dec 6, 2013 | K133207 | STAXX(R) SYSTEM Spine Wave, Inc. | MQP |
| Oct 4, 2013 | K132719 | STAXX IBL SYSTEM Spine Wave, Inc. | MAX |
| Aug 20, 2013 | K131071 | STAXX IBL SYSTEM Spine Wave, Inc. | MAX |
| Aug 9, 2013 | K132154 | CAPSURE PS SYSTEM Spine Wave, Inc. | MNI |
| Apr 11, 2013 | K123461 | STAXX(R) IB SYSTEM Spine Wave, Inc. | MAX |
| Oct 11, 2012 | K122233 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| Aug 29, 2012 | K121889 | STAXX XD SYSTEM Spine Wave, Inc. | MQP |
| Jun 7, 2012 | K120646 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| Dec 13, 2011 | K111418 | STAXX(R) XD SYSTEM Spine Wave, Inc. | MQP |
| Aug 31, 2011 | K111913 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| Aug 19, 2011 | K102315 | STAXX XDL SYSTEM Spine Wave, Inc. | MQP |
| Jul 19, 2011 | K111469 | STAXXSD SYSTEM Spine Wave, Inc. | MQP |
| Nov 30, 2010 | K102682 | STAXX(R) XD SYSTEM Spine Wave, Inc. | MQP |
| Sep 10, 2010 | K101288 | STAXX XD SYSTEM Spine Wave, Inc. | MQP |
| Jun 4, 2010 | K100605 | MIS SYSTEM Spine Wave, Inc. | MNH |
| Feb 12, 2010 | K100122 | MODIFICATION TO CAPSURE PS SYSTEM Spine Wave, Inc. | MNH |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2015 | Spine Wave, Inc. Spine Wave Access Kit, Catalog Number 10-1530
Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set.
Product Usage:
The Spine Wave Access Kit is comprise Terminated |
ETN | K072736 |
| Sep 11, 2013 | Spine Wave, Inc. StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902.
Indicated for intervertebral body fusion procedures in skeletally mature patients. Terminated |
MAX | K123461 |
| Jan 26, 2011 | Spine Wave Inc StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H)
Catalog number: 11-1525
The StaXx XD System is a vertebral body replacement device intended for use in the thoracol Terminated |
K101288 |