Spine Wave, Inc.
Spine Wave, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Spine Wave, Inc.
FDA recalls by Spine Wave, Inc.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Spine Wave, Inc.
- K260286 — Dynamo Spinal Cement; Salvo® Spine System
- K261159 — Exceed® Biplanar Expandable Interbody System
- K243816 — Testa TP Pivoting Spacer System
- K251131 — Annex® 2 Adjacent Level System
- K243514 — Salvo® Robotic Navigation Instruments
- K240685 — Salvo® Spine System
- K231275 — Exceed Biplanar Expandable Interbody System
- K222362 — Salvo® Spine System
- K202476 — Salvo® Spine System
- K192526 — Spine Wave Navigated Instruments
- K191045 — Salvo Spine System
- K182954 — Salvo Spine System
- K181596 — Spine Wave Navigated Instruments
- K181440 — Proficient® Posterior Cervical Spine System
- K172594 — Proficient® Posterior Cervical Spine System
- K173175 — Paramount Anterior Cervical Cage System
- K172175 — CapSure® PS System
- K163246 — Leva Anterior Expandable Spacer System
- K162760 — Spine Wave Anterior Cervical Spine System
- K162639 — Proficient Posterior Cervical Spine System
- K161993 — Leva® Anterior Interbody System
- K153222 — Leva Spacer System
- K160003 — Sniper (R) Spine System
- K152620 — Spine Wave Gen II Expandable Interbody System
- K152174 — Sniper Spine System
- K151813 — Sniper Spine System
- K151581 — Leva Spacer System
- K150285 — Leva(TM) Spacer System
- K142996 — StaXx(R) XD System
- K141980 — LEVA (TM) SPACER SYSTEM
- K142980 — Proficient (TM) Facet Screw Spine System
- K142101 — ABACUS (TM) SPACER SYSTEM
- K140007 — ABACUS TM SPACER SYSTEM
- K132403 — ANNEXTM ADJACENT LEVEL SYSTEM
- K133207 — STAXX(R) SYSTEM
- K132719 — STAXX IBL SYSTEM
- K131071 — STAXX IBL SYSTEM
- K132154 — CAPSURE PS SYSTEM
- K123461 — STAXX(R) IB SYSTEM
- K122233 — CAPSURE(R) PS SYSTEM
- K121889 — STAXX XD SYSTEM
- K120646 — CAPSURE(R) PS SYSTEM
- K111418 — STAXX(R) XD SYSTEM
- K111913 — CAPSURE(R) PS SYSTEM
- K102315 — STAXX XDL SYSTEM
- K111469 — STAXXSD SYSTEM
- K102682 — STAXX(R) XD SYSTEM
- K101288 — STAXX XD SYSTEM
- K100605 — MIS SYSTEM
- K100122 — MODIFICATION TO CAPSURE PS SYSTEM
- K090315 — STAXX XD SYSTEM
- K083743 — CAPSURE PS SYSTEM
- K083353 — CAPSURE(R) PS SYSTEM
- K081228 — CAPSURE PS (R) SPINE SYSTEM
- K063606 — MODIFICATION TO STAXX FX SYSTEM
- K070245 — CAPSURE PEDICLE SCREW SYSTEM
- K053336 — STAXX FX SYSTEM
- K052670 — STAXX XD SYSTEM
- K033303 — WAFER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.