Spine Wave Inc
Shelton, CT, US
SPINE WAVE, INC. appears in FDA device records in Shelton, CT. FDA records list 59 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for Spine Wave Inc between 2004 and 2026. The busiest year on record is 2015, with 7. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 4 |
| 2012 | 3 |
| 2013 | 5 |
| 2014 | 3 |
| 2015 | 7 |
| 2016 | 4 |
| 2017 | 6 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | PML | Substantially Equivalent | |
| K261159 | Exceed® Biplanar Expandable Interbody System | MAX | Substantially Equivalent | |
| K243816 | Testa TP Pivoting Spacer System | MAX | Substantially Equivalent | |
| K251131 | Annex® 2 Adjacent Level System | NKB | Substantially Equivalent | |
| K243514 | Salvo® Robotic Navigation Instruments | OLO | Substantially Equivalent | |
| K240685 | Salvo® Spine System | NKB | Substantially Equivalent | |
| K231275 | Exceed™ Biplanar Expandable Interbody System | MAX | Substantially Equivalent | |
| K222362 | Salvo® Spine System | NKB | Substantially Equivalent | |
| K202476 | Salvo® Spine System | NKB | Substantially Equivalent | |
| K192526 | Spine Wave Navigated Instruments | OLO | Substantially Equivalent | |
| K191045 | Salvo™ Spine System | NKB | Substantially Equivalent | |
| K182954 | Salvo™ Spine System | NKB | Substantially Equivalent | |
| K181596 | Spine Wave Navigated Instruments | OLO | Substantially Equivalent | |
| K181440 | Proficient® Posterior Cervical Spine System | NKG | Substantially Equivalent | |
| K172594 | Proficient® Posterior Cervical Spine System | NKG | Substantially Equivalent | |
| K173175 | Paramount Anterior Cervical Cage System | OVE | Substantially Equivalent | |
| K172175 | CapSure® PS System | NKB | Substantially Equivalent | |
| K163246 | Leva Anterior Expandable Spacer System | MAX | Substantially Equivalent | |
| K162760 | Spine Wave Anterior Cervical Spine System | OVE | Substantially Equivalent | |
| K162639 | Proficient™ Posterior Cervical Spine System | NKG | Substantially Equivalent | |
| K161993 | Leva® Anterior Interbody System | OVD | Substantially Equivalent | |
| K153222 | Leva Spacer System | MAX | Substantially Equivalent | |
| K160003 | Sniper (R) Spine System | MNI | Substantially Equivalent | |
| K152620 | Spine Wave Gen II Expandable Interbody System | MAX | Substantially Equivalent | |
| K152174 | Sniper Spine System | MNI | Substantially Equivalent | |
| K151813 | Sniper Spine System | MNI | Substantially Equivalent | |
| K151581 | Leva Spacer System | MAX | Substantially Equivalent | |
| K150285 | Leva(TM) Spacer System | MAX | Substantially Equivalent | |
| K142996 | StaXx(R) XD System | MQP | Substantially Equivalent | |
| K141980 | LEVA (TM) SPACER SYSTEM | MAX | Substantially Equivalent | |
| K142980 | Proficient (TM) Facet Screw Spine System | MRW | Substantially Equivalent | |
| K142101 | ABACUS (TM) SPACER SYSTEM | MAX | Substantially Equivalent | |
| K140007 | ABACUS TM SPACER SYSTEM | MAX | Substantially Equivalent | |
| K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | MNH | Substantially Equivalent | |
| K133207 | STAXX(R) SYSTEM | MQP | Substantially Equivalent | |
| K132719 | STAXX IBL SYSTEM | MAX | Substantially Equivalent | |
| K131071 | STAXX IBL SYSTEM | MAX | Substantially Equivalent | |
| K132154 | CAPSURE PS SYSTEM | MNI | Substantially Equivalent | |
| K123461 | STAXX(R) IB SYSTEM | MAX | Substantially Equivalent | |
| K122233 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | |
| K121889 | STAXX XD SYSTEM | MQP | Substantially Equivalent | |
| K120646 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | |
| K111418 | STAXX(R) XD SYSTEM | MQP | Substantially Equivalent | |
| K111913 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | |
| K102315 | STAXX XDL SYSTEM | MQP | Substantially Equivalent | |
| K111469 | STAXXSD SYSTEM | MQP | Substantially Equivalent | |
| K102682 | STAXX(R) XD SYSTEM | MQP | Substantially Equivalent | |
| K101288 | STAXX XD SYSTEM | MQP | Substantially Equivalent | |
| K100605 | MIS SYSTEM | MNH | Substantially Equivalent | |
| K100122 | MODIFICATION TO CAPSURE PS SYSTEM | MNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004638600 | 3004638600 | SPINE WAVE, INC. | THREE ENTERPRISE DR., SHELTON, CT 06484 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- PMLBone Cement, Posterior Screw Augmentation
- KTZCaliper
- GEACannula, Surgical, General & Plastic Surgery
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
- NDNCement, Bone, Vertebroplasty
- HTFCurette
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HTZInstrument, Cutting, Orthopedic
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GFIOsteotome, Manual
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- HXBProbe
- HTRRasp
- HTOReamer
- GADRetractor
- HTXRongeur
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- MRWSystem, Facet Screw Spinal Device
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1960-2015 | 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 comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm | Class II | Terminated | |
| Z-2187-2013 | 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. | A component Superior endplate manufactured from a different polymer than specified | Class II | Terminated | |
| Z-0967-2011 | 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 thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx XD System is the CapSure PS Spine System. | Package Insert Incorrect | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain