FDA.reportPublic FDA data

SPINEVISION INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30254570953025457095SPINEVISION INC.1Y2026-01-013321 Towerwood Dr Ste 130 Farmers Branch TX US 75234

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3125751222649278K223251Hexanium PLIFMAX2022-12-16
3125751170757977K221578Hexanium ACIFOVE2022-11-14
3125751070328615K210359Hexanium TLIFMAX2021-03-10
3125751311391409K193000Hexanium® ACIFOVE2020-10-20
3125751575301288K180437Hexanium® TLIFMAX2018-05-04
3125751892712334K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI2016-04-04
3125751386414565K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFMAX2016-05-04
3125751742749525K133575SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEMMNH2014-06-30
3125751461993281K130302SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXATMNI2013-07-30
3125751025936632K112607SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...NKB2012-06-07
3125751889876382K052406UNI-THREAD SPINAL SYSTEMMNI2005-11-07
3125751689290061K042930SPACEVISION CAGE SYSTEMMQP2004-12-28
3125751369310395K042640UNI-THREAD SPINAL SYSTEMMNH2004-11-23
3125751328407942K033508PLUS PIVOT LINK UNIVERSAL SYSTEMMNI2004-01-27
3125751367195211K032398PLUS PIVOT LINK UNIVERSAL SYSTEMMNI2003-10-31
3125751631328868K022271PLUS PIVOT LINK UNIVERSAL SYSTEMMNI2002-09-23
3125751699339193K021510UNI-T UNI-THREAD SPINAL SYSTEMMNI2002-08-01
3125751095666631K021507PLUS PIVOT LINK UNIVERSAL SYSTEMKWP2002-08-01
3125751423005877K013312P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)KWP2002-02-13
3125751327506600K013301UNI-T SPINAL SYSTEMMNI2002-02-13
3125751713611460K012881C3 ANTERIOR CERVICAL PLATE SYSTEMKWQ2001-11-26
3125751022749674
3125751054716124
3125751064541381
3125751072347730
3125751089628071
3125751115173251
3125751168733594
3125751191482664
3125751248026261
3125751259911058
3125751334582364
3125751335628234
3125751349839035
3125751495845824
3125751672521580
3125751702184808
3125751754646276
3125751804435611
3125751858564884
3125751879971638
3125751924670929
3125751957895654
3125751964326577
3125752000883393
3125752073602278

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MNI82016-04-04
MAX42022-12-16
OVE22022-11-14
MNH22014-06-30
KWP22002-08-01
NKB12012-06-07
MQP12004-12-28
KWQ12001-11-26