FDA.reportPublic FDA data

SPINEFRONTIER, INC. DBA LESspine Innovations

Matched from indexed company URL: SpineFrontier, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059772573005977257SPINEFRONTIER, INC. DBA LESspine Innovations1N2026-01-01200 Summit Drive Suite 505 Burlington MA US 01803

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
00190361000983Indus® - Invue Max, Single Level ACP, 17mm+1(866)914-7717customerservice@spinefrontier.com
00190361000990Indus® - Invue Max, Single Level ACP, 19mm+1(866)914-7717customerservice@spinefrontier.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
255731550857099K243774ELID (Endoscopic Less Invasive Decompression) SystemHRX2025-08-27
255731684345699K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation SystemOUR2023-09-28
255731421772728K193106SpineFrontier Lumbar Interbody Fusion Device SystemMAX2020-06-19
255731640227415K172484A-CIFT SoloFuseOVE2018-05-08
255731467366738K151198A-CIFT SoloFuseOVE2015-07-17
255731336124822K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemOUR2015-04-24
255731165271690K143377PedFuse Pedicle Screw SystemMNH2015-02-12
255731974574545K142026SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICEODP2014-10-20
255731195048093K141337ARENA-CODP2014-09-08
255731268622124K133153SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMMNH2014-05-14
255732072997140K131880SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEMOVE2014-01-03
255731809046573K123164SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMMNH2013-02-15
255731612035500K121060SPINE FRONTIER INDUS ACP SYSTEMKWQ2012-07-03
255731230368075K113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMODP2012-02-16
255731687765261K111553SPINEFRONTIER LUMBAR IBF SYSTEMMAX2011-09-28
255731704794182K102020VEGA SPAN SPINOUS PROCESS PLATE SYSTEMKWP2010-09-01
255731253663608K093776INDUS ANTERIOR CERVICAL PLATE SYSTEMKWQ2010-03-26
255731685075078K092815S-LIF INTERVERTEBRAL BODY FUSION DEVICEMAX2010-06-30
255731587028963K092420KRD1 PEDICLE SCREW SYSTEMMNI2009-11-19
255731396904735K091638DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031MAX2009-09-14
255731285148256K073232INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXXKWQ2008-02-20
255731210915434K072289SPINEFRONTIER DORADO VBRMAX2007-11-01
255731891842507K071420CHAMELEON FIXATION SYSTEMMRW2008-01-16
255731620733282K053213BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAMMQV2006-07-06
255731034747457
255731040023962
255731051326291
255731052352755
255731058065683
255731070407005
255731099499043
255731139996577
255731165772162
255731170465307
255731191857600
255731204305621
255731219124354
255731229351296
255731242856590
255731244409638
255731257927390
255731278861244
255731309213350
255731317165314
255731386077890
255731402331381
255731466705947
255731482478960
255731483639474
255731528839578
255731554005403
255731624525146
255731634984281
255731636102006
255731713651818
255731731290674
255731739898377
255731757554090
255731776711875
255731778352537
255731818266235
255731830116405
255731880281211
255731884840991
255731891712985
255731893193896
255731926573398
255731929862184
255731951355880
255731955485330
255731962894931
255731991576467
255732016356515
255732024098922
255732042637437
255732067293263

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52020-06-19
ODP52014-10-20
OVE42018-05-08
MNH42015-02-12
KWQ32012-07-03
OUR22023-09-28
HRX12025-08-27
KWP12010-09-01
MNI12009-11-19
MRW12008-01-16
MQV12006-07-06

PMN#

ARENA-C

2014-09-08

SPINEFRONTIER, INC.

GUDID#

200 records. Showing 1-40. Next