FDA.reportPublic FDA data

Corelink, LLC

Matched from indexed company URL: CORELINK LLC

FDA Registration(s)#

Registration, FEI, Name table
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 GUDID, Product, Phone table
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 key, Listing key, Premarket submission table
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 code, Registration listing records, Latest decision table
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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