FDA.report

Corelink, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30064942013006494201Corelink, LLC1N2020-04-252072 Fenton Logistics Park Blvd Fenton MO US 63026

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
M7253LL18350008CoreLink 3D Lateral Cage - Foundation 3D Lateral Cage - 18mm x 35mm x 8mm, 0°6019191119info@zavation.com
M7253LL18350010CoreLink 3D Lateral Cage - Foundation 3D Lateral Cage - 18mm x 35mm x 10mm, 0°6019191119info@zavation.com
M7253LL18350012CoreLink 3D Lateral Cage - Foundation 3D Lateral Cage - 18mm x 35mm x 12mm, 0°6019191119info@zavation.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1245551660817107K190016Lateral Plate SystemKWQ2019-06-12
1245551879564834K183239CoreLink F3D™ Lateral SystemMAX2018-12-19
1245551785197218K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemOVD2018-08-10
1245551825822782K180556Corelink Foundation 3D Anterior Lumbar SystemMAX2018-07-27
1245551153263785K171519FLXfit™MAX2017-09-15
1245551746783149K163104Terrace™ Anterior Cervical Plate SystemKWQ2017-06-21
1245551064080741K162496Foundation 3D InterbodyODP2017-05-04
1245551722946846K152237The Entasis Dual-Lead Sacroiliac ImplantOUR2016-02-04
1245552038555917K150847Foundation Interbody DevicesODP2015-08-13
1245551128894774K133813FLXFIT INTERVERTEBRAL BODY FUSION DEVICEMAX2014-07-15
1245551877055118K133369TIGER SPINE SYSTEMNKB2014-01-14
1245551903537573K132994ANODYNE ANTERIOR CERVICAL PLATE SYSTEMKWQ2013-12-05
1245551216544547K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMKWP2013-11-25
1245551972755619K131250TIGER SPINE SYSTEMNKB2013-09-10
1245551628240681K121791ZOU ANTERIOR LUMBAR PLATE SYSTEMKWQ2012-11-19
1245551967414333K121728TIGER SPINE SYSTEMNKB2012-10-05
1245551688488686K121514ANODYNE ANTERIOR CERVICAL PLATE SYSTEMKWQ2012-12-14
1245551079559019K120696TIGER SPINE SYSTEMMNI2012-04-02
1245552039607783K113058TIGER SPINE SYSTEMNKB2012-03-29
1245551783294090K110321TIGER SPINE SYSTEMMNH2011-05-25
1245551363243904K073440FOUNDATION CAGEMAX2008-04-24
1245551115438243
1245551143889145
1245551195179053
1245551232761179
1245551297776187
1245551483234808
1245551533712907
1245551558362316
1245551673734784
1245551716358172
1245551716443892
1245551769126129
1245551785833323
1245551815931033
1245551843457796
1245551844438504
1245551859069360
1245551904881063
1245551983426554
1245552003328085
1245552009203135

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KWQ52019-06-12
MAX52018-12-19
NKB42014-01-14
ODP22017-05-04
OVD12018-08-10
OUR12016-02-04
KWP12013-11-25
MNI12012-04-02
MNH12011-05-25

PMN

GUDID

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