FDA.report

Innovasis

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30047196933004719693INNOVASIS, INC.1Y2026-01-01614 E 3900 S Millcreek UT US 84107
30047196933004719693INNOVASIS, INC.1Y2020-04-25614 E 3900 S SALT LAKE CITY UT US 84107

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
M711LAA0550A-Box® - A-Box Mallet 1lb., SST801-261-2236info@innovasis.com
M711LAA0600A-Box® - Osteotome Assembly, Ti 6Al 4V, SST801-261-2236info@innovasis.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3451911847068774K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)OLO2025-07-23
3451911693389590K250603AxTiHA® Stand-Alone ALIF SystemOVD2025-03-24
3451911958754840K250182Innovasis Navigation InstrumentsOLO2025-03-24
3451911111475987K250076Endeavor™ Stand-Alone Cervical IBF SystemOVE2025-09-25
3451911900436749K241276Vector™ Pedicle Screw SystemNKB2024-05-20
3451911680976299K231899HAtetracell™-C Titanium Cervical IBF SystemODP2023-10-17
3451911556113561K223511Excella Navigation InstrumentsOLO2023-05-02
3451912000078808K212967AxTiHA Stand-Alone ALIF SystemOVD2021-10-15
3451911869494358K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemMAX2020-07-15
3451911503982435K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndFST2020-06-30
635091087397445K192354Innovasis Gibralt Spine SystemNKG2019-09-24
3451911724948665K192354Innovasis Gibralt Spine SystemNKG2019-09-24
3451911938270796K192049Oryx Cervical Plate SystemKWQ2019-11-08
635091428289126K191764Inion BioRestoreMQV2019-07-31
3451911521391665K190684LxHA PEEK Lateral IBF SystemMAX2019-06-17
635091594478083K190684LxHA PEEK Lateral IBF SystemMAX2019-06-17
635091853101603K183064TxTi IBF SystemMAX2019-06-28
635091040504598K182139AXTi Titanium Stand-Alone ALIF SystemOVD2019-06-21
3451911064106451K181115CxHA PEEK Cervical IBF SystemODP2018-07-16
635092068851976K181115CxHA PEEK Cervical IBF SystemODP2018-07-16
3451911006216135K181063Kestrel™ Buttress Plate SystemKWQ2018-07-13
635091785088303K181063Kestrel™ Buttress Plate SystemKWQ2018-07-13
3451911170191087K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemMAX2018-04-17
635091665236445K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemMAX2018-04-17
635091136237750K162236Ax Stand-Alone ALIF SystemOVD2017-04-20
3451911622747969K162236Ax Stand-Alone ALIF SystemOVD2017-04-20
635091089300058K162143FixxSure® X-LinkMNH2016-09-23
3451911401369137K162143FixxSure® X-LinkMNH2016-09-23
635091206321895K160697Gibralt® Spine System and Gibralt® Occipital Spine SystemNKG2016-06-28
3451911008436755K151785Px HA PEEK IBF SystemMAX2015-10-14
635091350574965K151785Px HA PEEK IBF SystemMAX2015-10-14
3451911640220748K150500Px PEEK IBF SystemMAX2015-06-19
635091833826069K150500Px PEEK IBF SystemMAX2015-06-19
635091786137912K141644INNOVASIS CRANIAL SYSTEMGWO2014-11-07
3451911808470994K141644INNOVASIS CRANIAL SYSTEMGWO2014-11-07
635091179593958K141452LEFORTE NEURO SYSTEM BONE PLATE AND SCREWGWO2014-07-02
3451912067509807K141452LEFORTE NEURO SYSTEM BONE PLATE AND SCREWGWO2014-07-02
3451911397572978K140238EXCELLA III-D SPINAL DEFORMITY SYSTEMNKB2014-05-07
635092009718701K140238EXCELLA III-D SPINAL DEFORMITY SYSTEMNKB2014-05-07
3451911117728687K133340SPINEWORKS ANTERIOR LUMBAR DEVICEMAX2014-04-11
635092073294675K133340SPINEWORKS ANTERIOR LUMBAR DEVICEMAX2014-04-11
3451911052529037K132991C-BOX PEEK CERVICAL IBFODP2014-02-12
635091382396202K132991C-BOX PEEK CERVICAL IBFODP2014-02-12
635091006340921K121581BOX PEEK VBR SYSTEM,MAX2012-10-17
3451912060020796K121581BOX PEEK VBR SYSTEM,MAX2012-10-17
635091116756775K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYMBP2012-11-15
635092070957383K110976ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBMMQV2011-05-03
635091410835371K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00NKB2010-10-07
3451911602812532K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00NKB2010-10-07
635091046004328K101563SMARTOKIJ2010-12-17
3451911480936055K101563SMARTOKIJ2010-12-17
635091272938560K091686LEFORTE NEUROSYSTEM BONE SCREWHWC2009-11-13
635091085500781K091679LEFORTE SYSTEM BONE PLATEJEY2009-10-02
635091541230939K090177INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTEMQV2009-02-20
635091742992644K081331FIXXSURE CROSS LINKMNH2008-07-23
3451911763002799K081331FIXXSURE CROSS LINKMNH2008-07-23
3451911732863824K071921INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)NKB2007-11-16
635092066100413K071921INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)NKB2007-11-16
3451911640981996K062151BOX PEEK VBR SYSTEMMQP2006-12-22
635091671511898K062151BOX PEEK VBR SYSTEMMQP2006-12-22
635091058030547K061147OPTERYX ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-06-30
3451912051815213K061147OPTERYX ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-06-30
3451911208999763K042600STANSION MATRIXMQP2005-02-18
635091354106224K042600STANSION MATRIXMQP2005-02-18
3451911581174078K042143EXCELLA-M SPINAL SYSTEMKWP2004-10-07
635092039404131K042143EXCELLA-M SPINAL SYSTEMKWP2004-10-07
635091726945160
635092006398493
3451911429132786
3451911761882519
3451911973741348

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MAX142020-07-15
NKB72024-05-20
OVD52025-03-24
ODP52023-10-17
KWQ52019-11-08
MNH42016-09-23
GWO42014-11-07
MQP42006-12-22
OLO32025-07-23
NKG32019-09-24
MQV32019-07-31
KIJ22010-12-17
KWP22004-10-07
OVE12025-09-25
FST12020-06-30
MBP12012-11-15
HWC12009-11-13
JEY12009-10-02

PMN

GUDID

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