Data / Medical devices / United States / Spine Wave, Inc.
Spine Wave, Inc.: FDA-registered device maker in Shelton, CT, United States, 53 510(k) clearances
Spine Wave, Inc. is registered with the FDA (registration 3004638600) in Shelton, CT, United States. It lists 35 device types. The FDA files 53 510(k) clearances under its listings, the newest dated June 15, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004638600
- Address
- Three Enterprise DR. Suite 210, Shelton, CT, United States, 06484
- Owner or operator
- SPINE WAVE, INC. (9055730)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 1, 2004
- Registered through
- 2026
- Brand names listed
- AWL, Abacus Spacer System, Accent® Cervical Spacer System, Annex® 2 Adjacent Level System, BONE RASP, BONE TAP, CAP DRIVER, CAPSURE PS SPINE SYSTEM and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 15, 2026 | K260286 | Dynamo Spinal Cement; Salvo® Spine System | PML | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| May 29, 2026 | K261159 | Exceed® Biplanar Expandable Interbody System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| June 27, 2025 | K243816 | Testa TP Pivoting Spacer System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| June 6, 2025 | K251131 | Annex® 2 Adjacent Level System | NKB | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| April 3, 2025 | K243514 | Salvo® Robotic Navigation Instruments | OLO | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| May 6, 2024 | K240685 | Salvo® Spine System | NKB | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| July 25, 2023 | K231275 | Exceed Biplanar Expandable Interbody System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| August 29, 2022 | K222362 | Salvo® Spine System | NKB | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| November 5, 2020 | K202476 | Salvo® Spine System | NKB | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| October 10, 2019 | K192526 | Spine Wave Navigated Instruments | OLO | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| July 10, 2019 | K191045 | Salvo Spine System | NKB | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| January 16, 2019 | K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | KWQ | Substantially Equivalent | Solco Biomedical Co., Ltd. | accessdata.fda.gov |
| December 12, 2018 | K182954 | Salvo Spine System | NKB | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| October 24, 2018 | K181596 | Spine Wave Navigated Instruments | OLO | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| September 19, 2018 | K181229 | TirboLOX-C Cervical IBFD | ODP | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| August 13, 2018 | K180990 | TirboLOX-L Lumbar IBFD | MAX | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| July 30, 2018 | K181440 | Proficient® Posterior Cervical Spine System | NKG | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| December 15, 2017 | K172594 | Proficient® Posterior Cervical Spine System | NKG | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| November 1, 2017 | K173175 | Paramount Anterior Cervical Cage System | OVE | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| April 6, 2017 | K163246 | Leva Anterior Expandable Spacer System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| February 16, 2017 | K162760 | Spine Wave Anterior Cervical Spine System | OVE | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| February 7, 2017 | K162639 | Proficient Posterior Cervical Spine System | NKG | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| November 22, 2016 | K161993 | Leva® Anterior Interbody System | OVD | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| April 15, 2016 | K153222 | Leva Spacer System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| February 26, 2016 | K160003 | Sniper (R) Spine System | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| January 15, 2016 | K152620 | Spine Wave Gen II Expandable Interbody System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| August 31, 2015 | K152174 | Sniper Spine System | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| July 31, 2015 | K151813 | Sniper Spine System | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| July 9, 2015 | K151581 | Leva Spacer System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| March 5, 2015 | K150285 | Leva(TM) Spacer System | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| February 19, 2015 | K142996 | StaXx(R) XD System | MQP | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| January 26, 2015 | K141980 | LEVA (TM) SPACER SYSTEM | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| April 7, 2014 | K140007 | ABACUS TM SPACER SYSTEM | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| January 10, 2014 | K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | MNH | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| December 6, 2013 | K133207 | STAXX(R) SYSTEM | MQP | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| October 4, 2013 | K132719 | STAXX IBL SYSTEM | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| August 9, 2013 | K132154 | CAPSURE PS SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| April 11, 2013 | K123461 | STAXX(R) IB SYSTEM | MAX | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| October 11, 2012 | K122233 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| August 29, 2012 | K121889 | STAXX XD SYSTEM | MQP | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| June 7, 2012 | K120646 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| December 13, 2011 | K111418 | STAXX(R) XD SYSTEM | MQP | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| August 31, 2011 | K111913 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| November 30, 2010 | K102682 | STAXX(R) XD SYSTEM | MQP | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| September 10, 2010 | K101288 | STAXX XD SYSTEM | MQP | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| August 10, 2010 | K100743 | ATLAS SPINE PIVOTING SYSTEM | MAX | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| June 4, 2010 | K100605 | MIS SYSTEM | MNH | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| February 12, 2010 | K100122 | MODIFICATION TO CAPSURE PS SYSTEM | MNH | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| December 22, 2009 | K091926 | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM | KWQ | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| November 2, 2009 | K091531 | CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER | ODP | Substantially Equivalent | Choice Spine, Llp | accessdata.fda.gov |
| December 11, 2008 | K083353 | CAPSURE(R) PS SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| May 12, 2008 | K081228 | CAPSURE PS (R) SPINE SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
| April 5, 2007 | K070245 | CAPSURE PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | Spine Wave, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 4, 2015 | 71497 | Class II | Terminated | 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 monopo | Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm | accessdata.fda.gov |
| May 14, 2013 | 65968 | Class II | Terminated | 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 | accessdata.fda.gov |
| October 22, 2010 | 57188 | Not yet classified | Terminated | 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) | Package Insert Incorrect | accessdata.fda.gov |
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Updated June 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.