FDA.reportPublic FDA data

Precision Spine, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057398863005739886Precision Spine, Inc.1N2026-01-012050 Executive Dr Pearl MS US 39208

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
667541542192386K250769Dakota LP SystemODP2025-11-24
667541360675250K242297Reform Pedicle Screw SystemNKB2024-12-17
667541500529280K231229S-COMP Reform® POCT Navigation InstrumentsOLO2023-05-25
667541350063867K220862E-GPS Navigated InstrumentsOLO2022-07-14
667541205393303K220324AccuFit Lateral 2-Hole PlateKWQ2022-03-16
667541336749290K213118Dakota ALIF SystemOVD2022-04-01
667541305226323K212937Dakota ALIF Plate SystemKWQ2021-11-04
667541791326860K212075ShurFit Lumbar Interbody SystemMAX2021-12-08
667541987003352K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemOVE2021-01-12
667541098470331K200303Reform Pedicle Screw SystemNKB2020-05-19
667541973634250K192494NexGen Anterior Cervical Plate SystemKWQ2019-10-29
667541054802787K181606Precision Spine Navigation InstrumentationOLO2019-09-27
667541112825498K173130Reform® Midline Cortical Screw SystemNKB2017-12-19
667541288813489K172495Reform® POCT SystemNKG2018-04-11
667541234782815K171657ShurFit 2C Lumbar Interbody Fusion SystemMAX2017-08-11
667541691289110K162300Reform® POCT SystemNKG2016-11-22
667541159660485K162211AccuFit Lateral Plate SystemKWQ2016-11-28
667541265925914K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemODP2016-12-06
667541949474889K160568Precision Spine Interspinous Plate SystemPEK2016-05-04
667541022874101K151863Precision Spine Interspinous Plate SystemPEK2015-08-07
667541325412110K151422Reform Pedicle Screw SystemNKB2015-08-21
667541800201035K150856Reform Pedicle Screw SystemNKB2015-07-07
667541163311098K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP2015-06-04
667541886303391K143248Reform Pedicle Screw SystemNKB2014-12-19
667541029141542K142378Interspinous Plate SystemPEK2014-12-18
667541249276461K141397SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEMMNI2014-06-26
667542044224848K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEOVE2013-11-25
667541753375309K131343REFORM PEDICLE SCREW SYSTEMMNI2013-07-24
667541400490773K130863FACET SCREW SYSTEMMRW2013-08-09
667542010391738K130445VAULT ALIF SYSTEMOVD2013-04-25
667541732256456K130279REFORM PEDICLE SCREW SYSTEMMNI2013-06-20
667541415997617K122931S-LOK PSS SYSTEMMNI2012-11-20
667541902653812K121172REFORM PEDICLE SCREW SYSTEMMNI2012-08-08
667541642874125K112748SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEMKWQ2012-07-11
667541850737735K112025SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEMKWP2011-09-15
667541259007239K103369VAULT ALIF SYSTEMOVD2011-04-04
667541155706473K092659SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25KWQ2009-11-17
667542004814395K092193SPINAL USA INTERBODY CAGESMAX2009-09-25
667541816370311K092128MODIFICATION TO: PSS SYSTEMMNI2009-09-14
667541987703585K091044SPINAL USA ANTERIOR LUMBAR PLATE SYSTEMKWQ2009-07-09
667541552078578K090033MODIFICATION TO: PSS SYSTEMMNI2009-05-06
667541093725266K083118SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICEODP2009-05-27
667541127955695K081196SPINAL USA VBR SYSTEMMAX2008-10-16
667541905754622K080314SPINAL USA INTERBODY FUSION DEVICEMAX2008-05-13
667541413643899K073240PSS SYSTEMMNI2008-03-20
667541712526482K071438PSS SYSTEMMNI2007-08-21
667541540790053K070922MODIFICATION TO SPINAL USA VBR SYSTEMKWQ2007-09-19
667541987682481K070922MODIFICATION TO SPINAL USA VBR SYSTEMKWQ2007-09-19
667541529309683K060132SPINAL USA CEMENT RESTRICTOR SYSTEMJDK2006-03-16
667541848417257K060025SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-04-18
667541003876630
667541017068898
667541037668283
667541050579207
667541053976978
667541092558918
667541137671642
667541141549241
667541256827861
667541286058987
667541305348875
667541377313175
667541437035484
667541467628978
667541547768058
667541570445581
667541595101594
667541597767938
667541670124352
667541738616942
667541755282913
667541858888352
667541870434085
667541891505085
667541943763708
667541946760501
667541968967015
667541971340855
667541994113745
667541996846800
667542050257801
667542071309824

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ102022-03-16
MNI92014-06-26
NKB62024-12-17
MAX52021-12-08
ODP32025-11-24
OLO32023-05-25
OVD32022-04-01
PEK32016-05-04
OVE22021-01-12
NKG22018-04-11
KWP22015-06-04
MRW12013-08-09
JDK12006-03-16

PMN#

GUDID#

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