FDA.reportPublic FDA data

SPINE WAVE, INC.

Matched from indexed company URL: Spine Wave, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30046386003004638600SPINE WAVE, INC.1N2026-01-01THREE ENTERPRISE DR. SUITE 210 SHELTON CT US 06484

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10840642174410Salvo® Spine System - 8.5 x 70 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com
10840642174434Salvo® Spine System - 8.5 x 80 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com
10840642174632Salvo® Spine System - 9.5 x 60 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com
10840642174649Salvo® Spine System - 9.5 x 65 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com
10840642174694Salvo® Spine System - 9.5 x 90 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com
10840642174878Salvo® Spine System - 10.5 x 60 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com
10840642174892Salvo® Spine System - 10.5 x 70 mm Bone Screw, Cannulated, 3 mm Pitch203-944-9494info@spinewave.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
616851280346613K251131Annex® 2 Adjacent Level SystemNKB2025-06-06
616851059911211K243816Testa TP Pivoting Spacer SystemMAX2025-06-27
616851265524095K243514Salvo® Robotic Navigation InstrumentsOLO2025-04-03
616851148141640K240685Salvo® Spine SystemNKB2024-05-06
616851778887291K231275Exceed™ Biplanar Expandable Interbody SystemMAX2023-07-25
616851006935382K222362Salvo® Spine SystemNKB2022-08-29
616851138093516K202476Salvo® Spine SystemNKB2020-11-05
616851635303178K192526Spine Wave Navigated InstrumentsOLO2019-10-10
616851591593191K191045Salvo™ Spine SystemNKB2019-07-10
616851270384960K182954Salvo™ Spine SystemNKB2018-12-12
616851727056205K1824894CIS® Pinehurst Anterior Cervical Plate systemKWQ2019-01-16
616851856144885K181596Spine Wave Navigated InstrumentsOLO2018-10-24
616852027727519K181440Proficient® Posterior Cervical Spine SystemNKG2018-07-30
616851504863214K181229TirboLOX-C Cervical IBFDODP2018-09-19
616851808466179K180990TirboLOX-L Lumbar IBFDMAX2018-08-13
616851232272510K173175Paramount Anterior Cervical Cage SystemOVE2017-11-01
616851160739270K172594Proficient® Posterior Cervical Spine SystemNKG2017-12-15
616851286212811K163246Leva Anterior Expandable Spacer SystemMAX2017-04-06
616851893135595K162760Spine Wave Anterior Cervical Spine SystemOVE2017-02-16
616851105612586K162639Proficient™ Posterior Cervical Spine SystemNKG2017-02-07
616851269529834K161993Leva® Anterior Interbody SystemOVD2016-11-22
616851159013869K160003Sniper (R) Spine SystemMNI2016-02-26
616851154668384K153222Leva Spacer SystemMAX2016-04-15
616851575342093K152620Spine Wave Gen II Expandable Interbody SystemMAX2016-01-15
616851974848216K152174Sniper Spine SystemMNI2015-08-31
616851253616913K151813Sniper Spine SystemMNI2015-07-31
616852073013678K151581Leva Spacer SystemMAX2015-07-09
616851250610073K150285Leva(TM) Spacer SystemMAX2015-03-05
616851834634029K142996StaXx(R) XD SystemMQP2015-02-19
616851854557956K141980LEVA (TM) SPACER SYSTEMMAX2015-01-26
616851173731152K140007ABACUS TM SPACER SYSTEMMAX2014-04-07
616851571258467K133207STAXX(R) SYSTEMMQP2013-12-06
616851193034951K132719STAXX IBL SYSTEMMAX2013-10-04
616851509383471K132403ANNEXTM ADJACENT LEVEL SYSTEMMNH2014-01-10
616851481253625K132154CAPSURE PS SYSTEMMNI2013-08-09
616851024303708K123461STAXX(R) IB SYSTEMMAX2013-04-11
616851142854371K122233CAPSURE(R) PS SYSTEMMNI2012-10-11
616851335223574K121889STAXX XD SYSTEMMQP2012-08-29
616851879923506K120646CAPSURE(R) PS SYSTEMMNI2012-06-07
616851711701748K111913CAPSURE(R) PS SYSTEMMNI2011-08-31
616851561251870K111418STAXX(R) XD SYSTEMMQP2011-12-13
616851104728259K102682STAXX(R) XD SYSTEMMQP2010-11-30
616851156483330K101288STAXX XD SYSTEMMQP2010-09-10
616851094866576K100743ATLAS SPINE PIVOTING SYSTEMMAX2010-08-10
616852032073813K100605MIS SYSTEMMNH2010-06-04
616852070916475K100122MODIFICATION TO CAPSURE PS SYSTEMMNH2010-02-12
616851483475730K091926CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEMKWQ2009-12-22
616851810949185K091531CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACERODP2009-11-02
616852073488144K083743CAPSURE PS SYSTEMMNI2009-01-13
616851164222458K083353CAPSURE(R) PS SYSTEMMNI2008-12-11
616851814271104K081228CAPSURE PS (R) SPINE SYSTEMMNI2008-05-12
616851179796796K070245CAPSURE PEDICLE SCREW SYSTEMMNI2007-04-05
616851034832481
616851302245428
616851574999222
616851758368115
616851841667438
616851979039629
616852071316300
616851143039623
616851154610954
616851182630359
616851244401590
616851314450827
616851497038192
616851497389234
616851601382353
616851605450605
616851637133040
616851647740062
616851656644884
616851697632668
616851743821912
616851758766758
616851861348659
616851864129592
616851951498590
616852025682491
616852054502802

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX132025-06-27
MNI112016-02-26
NKB62025-06-06
MQP62015-02-19
OLO32025-04-03
NKG32018-07-30
MNH32014-01-10
KWQ22019-01-16
ODP22018-09-19
OVE22017-11-01
OVD12016-11-22

PMN#

57 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next