Innovasis Inc

FDA Filings

This page includes the latest FDA filings for Innovasis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004719693
FEI Number3004719693
NameINNOVASIS, INC.
Owner & OperatorINNOVASIS, INC.
Contact Address614 EAST 3900 SOUTH --
Salt Lake City UT 84107 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address614 E 3900 S
SALT LAKE CITY, UT 84107 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Innovasis, Inc.
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System2020-07-15
Innovasis, Inc.
Excella MIS® LS-3512020-07-10
Innovasis, Inc.
Opteryx® CI-1102020-04-06
Innovasis, Inc.
Opteryx® CI-0502020-04-06
Innovasis, Inc.
Opteryx® CI-0402020-04-06
Innovasis, Inc.
AXTi™ AXTi1040082020-02-24
Innovasis, Inc.
AXTi™ AXTi1036082020-02-24
Innovasis, Inc.
AXTi™ AXTi1030142020-02-24
Innovasis, Inc.
AXTi™ AXTi1030082020-02-24
Innovasis, Inc.
A-Box® AB2040122020-02-24
Innovasis, Inc.
A-Box® AB2040062020-02-24
Innovasis, Inc.
A-Box® AB2034122020-02-24
Innovasis, Inc.
A-Box® AB2034062020-02-24
Innovasis, Inc.
A-Box® AB2028122020-02-24
Innovasis, Inc.
A-Box® AB2028062020-02-24
Innovasis, Inc.
A-Box® AB1840122020-02-24
Innovasis, Inc.
A-Box® AB1840062020-02-24
Innovasis, Inc.
A-Box® AB1834122020-02-24
Innovasis, Inc.
A-Box® AB1834062020-02-24
Innovasis, Inc.
A-Box® AB1828122020-02-24
Innovasis, Inc.
A-Box® AB1828062020-02-24
Innovasis, Inc.
A-Box® AB1640122020-02-24
Innovasis, Inc.
A-Box® AB1640062020-02-24
Innovasis, Inc.
A-Box® AB1634122020-02-24
Innovasis, Inc.
A-Box® AB1634062020-02-24
Innovasis, Inc.
A-Box® AB1628122020-02-24
Innovasis, Inc.
A-Box® AB1628062020-02-24
Innovasis, Inc.
A-Box® AB1440122020-02-24
Innovasis, Inc.
A-Box® AB1440062020-02-24
Innovasis, Inc.
A-Box® AB1434122020-02-24
Innovasis, Inc.
A-Box® AB1434062020-02-24
Innovasis, Inc.
A-Box® AB1428122020-02-24
Innovasis, Inc.
A-Box® AB1428062020-02-24
Innovasis, Inc.
A-Box® AB1240122020-02-24
Innovasis, Inc.
A-Box® AB1240062020-02-24
Innovasis, Inc.
A-Box® AB1234122020-02-24
Innovasis, Inc.
A-Box® AB1234062020-02-24
Innovasis, Inc.
A-Box® AB1228122020-02-24
Innovasis, Inc.
A-Box® AB1228062020-02-24
Innovasis, Inc.
A-Box® AB1040122020-02-24
Innovasis, Inc.
A-Box® AB1040062020-02-24
Innovasis, Inc.
A-Box® AB1034122020-02-24
Innovasis, Inc.
A-Box® AB1034062020-02-24
Innovasis, Inc.
A-Box® AB1028122020-02-24
Innovasis, Inc.
A-Box® AB1028062020-02-24
Innovasis, Inc.
A-Box® AB0840062020-02-24
Innovasis, Inc.
A-Box® AB0834062020-02-24
Innovasis, Inc.
A-Box® AB0828122020-02-24
Innovasis, Inc.
A-Box® AB0828062020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1830-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1830-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1826-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1826-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1630-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1630-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1626-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1626-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1430-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1430-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1426-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1426-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1230-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1230-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1226-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1226-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1030-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1030-112020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1026-62020-02-24
Innovasis, Inc.
SpineWorks Anterior Lumbar Device A1026-112020-02-24
Innovasis, Inc.
X-Box 90814252020-02-24
Innovasis, Inc.
X-Box 90812252020-02-24
Innovasis, Inc.
X-Box 90810252020-02-24
Innovasis, Inc.
X-Box 90808252020-02-24
Innovasis, Inc.
X-Box 88814252020-02-24
Innovasis, Inc.
X-Box 88814222020-02-24
Innovasis, Inc.
X-Box 88812252020-02-24
Innovasis, Inc.
X-Box 88812222020-02-24
Innovasis, Inc.
X-Box 88810252020-02-24
Innovasis, Inc.
X-Box 88810222020-02-24
Innovasis, Inc.
X-Box 88808252020-02-24
Innovasis, Inc.
X-Box 88808222020-02-24
Innovasis, Inc.
X-Box 88016252020-02-24
Innovasis, Inc.
X-Box 88014252020-02-24
Innovasis, Inc.
X-Box 88012252020-02-24
Innovasis, Inc.
X-Box 88010252020-02-24
Innovasis, Inc.
X-Box 88008252020-02-24
Innovasis, Inc.
X-Box 81014222020-02-24
Innovasis, Inc.
X-Box 81012222020-02-24
Innovasis, Inc.
X-Box 81010222020-02-24
Innovasis, Inc.
X-Box 81008222020-02-24
Innovasis, Inc.
X-Box 80814222020-02-24
Innovasis, Inc.
X-Box 80812222020-02-24
Innovasis, Inc.
X-Box 80810222020-02-24
Innovasis, Inc.
X-Box 80808222020-02-24
Innovasis, Inc.
C-Box® 12512132020-02-24
Innovasis, Inc.
C-Box® 12511132020-02-24
Innovasis, Inc.
C-Box® 12510132020-02-24
Innovasis, Inc.
C-Box® 12509132020-02-24
Innovasis, Inc.
C-Box® 12508132020-02-24
Innovasis, Inc.
C-Box® 12507132020-02-24
Innovasis, Inc.
C-Box® 12506132020-02-24
Innovasis, Inc.
Oryx Cervical Plate System2019-11-08
INNOVASIS, INC.
BioRestore2019-11-08
INNOVASIS, INC.
Gibralt2019-11-05
INNOVASIS, INC.
Gibralt2019-11-05
Innovasis, Inc.
Innovasis Gibralt Spine System2019-09-24
INNOVASIS, INC.
TxTi?2019-07-16
Innovasis, Inc.
TxTi IBF System2019-06-28
INNOVASIS, INC.
LxHA2019-06-27
INNOVASIS, INC.
AXTi2019-06-27
Innovasis, Inc.
AXTi Titanium Stand-Alone ALIF System2019-06-21
Innovasis, Inc.
LxHA PEEK Lateral IBF System2019-06-17
INNOVASIS, INC.
Gibralt Spine System2018-08-30
INNOVASIS, INC.
Gibralt Spine System2018-08-30
INNOVASIS, INC.
CxHA PEEK Cervical IBF System2018-07-27
INNOVASIS, INC.
Cx Cervical IBF System2018-07-27
INNOVASIS, INC.
Kestrel Buttress Plate System2018-07-27
Innovasis, Inc.
CxHA PEEK Cervical IBF System2018-07-16
Innovasis, Inc.
Kestrel™ Buttress Plate System2018-07-13
INNOVASIS, INC.
TxHA PEEK IBF System2018-05-08
INNOVASIS, INC.
Px PEEK IBF System2018-05-08
INNOVASIS, INC.
Px HA PEEK IBF System2018-05-08
Innovasis, Inc.
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System2018-04-17
INNOVASIS, INC.
Neuro & Craniofacial Fixation System2017-06-08
INNOVASIS, INC.
Neuro & Craniofacial Fixation System2017-06-08
INNOVASIS, INC.
Neuro & Craniofacial Fixation System2017-06-08
INNOVASIS, INC.
Neuro & Craniofacial Fixation System2017-06-08
INNOVASIS, INC.
Neuro & Craniofacial Fixation System2017-06-08
INNOVASIS, INC.
Neuro & Craniofacial Fixation System2017-06-08
INNOVASIS, INC.
Ax Stand-Alone ALIF System2017-04-20
INNOVASIS, INC.
Ax Stand-Alone ALIF2017-04-20
INNOVASIS, INC.
SpineWorks? FixxSure? X-Link2016-10-07
INNOVASIS, INC.
FixxSure? X-Link2016-10-07
INNOVASIS, INC.
SpineWorks? FixxSure? X-Link2016-10-07
INNOVASIS, INC.
FixxSure? X-Link2016-10-07
INNOVASIS, INC.
FixxSure® X-Link2016-09-23
INNOVASIS, INC.
Px HA PEEK IBF System2015-11-25
INNOVASIS, INC.
Px HA PEEK IBF System2015-10-14
INNOVASIS, INC.
Px PEEK IBF System2015-07-13
INNOVASIS, INC.
Px PEEK IBF System2015-06-19
INNOVASIS, INC.
SpineWorks ALD2014-12-09
INNOVASIS, INC.
SW ALD2014-12-09
INNOVASIS, INC.
FixxSure Crosslink2014-12-09
INNOVASIS, INC.
FixxSure Crosslink2014-12-09
INNOVASIS, INC.
Stansion Matrix2014-12-09
INNOVASIS, INC.
SpineWorks ALIF Instruments2014-12-09
INNOVASIS, INC.
Pedicle Subtraction Osteotomy Set2014-12-09
INNOVASIS, INC.
Innovasis Disc Prep2014-12-09
INNOVASIS, INC.
Innovasis Cranial System2014-11-25
INNOVASIS, INC.
Innovasis Cranial System2014-11-25
INNOVASIS, INC.
Innovasis Cranial System2014-11-25
INNOVASIS, INC.
INNOVASIS CRANIAL SYSTEM2014-11-07
INNOVASIS, INC.
PFX SPINOUS PROCESS FIXATION SYSTEM2014-07-14
INNOVASIS, INC.
Excella III-D2014-05-08
INNOVASIS, INC.
Excella III-D2014-05-08
INNOVASIS, INC.
Excella III-D2014-05-08
INNOVASIS, INC.
Excella III-D2014-05-08
INNOVASIS, INC.
Excella III-D2014-05-08
INNOVASIS, INC.
EXCELLA III-D SPINAL DEFORMITY SYSTEM2014-05-07
INNOVASIS, INC.
C-Spacer2014-02-26
INNOVASIS, INC.
C-Box2014-02-26
INNOVASIS, INC.
C-BOX PEEK CERVICAL IBF2014-02-12
INNOVASIS, INC.
Innovasis DBM Putty2013-11-22
INNOVASIS, INC.
Innovasis DBM Putty2013-11-22
INNOVASIS, INC.
BioRestore2013-11-22
INNOVASIS, INC.
Spacer Anterior Spinal System2012-10-22
INNOVASIS, INC.
L-Box Lateral Spinal System2012-10-22
INNOVASIS, INC.
L-Box IBF2012-10-22
INNOVASIS, INC.
Box IBF2012-10-22
INNOVASIS, INC.
Box IBF System2012-10-22
INNOVASIS, INC.
A-Box IBF2012-10-22
INNOVASIS, INC.
A-Box Anterior Spinal System2012-10-22
INNOVASIS, INC.
Innovasis DBM Putty2012-10-22
INNOVASIS, INC.
Innovasis DBM Putty2012-10-22
INNOVASIS, INC.
BOX PEEK VBR SYSTEM,2012-10-17
INNOVASIS, INC.
Excella III-D2010-12-07
INNOVASIS, INC.
Excella II Spinal System2010-12-07
INNOVASIS, INC.
Ethos Spinal System2010-12-07
INNOVASIS, INC.
Excella III-D2010-12-07
INNOVASIS, INC.
Excella II Spinal System2010-12-07
INNOVASIS, INC.
Ethos Spinal System2010-12-07
INNOVASIS, INC.
Excella III-D2010-12-07
INNOVASIS, INC.
Excella II Spinal System2010-12-07
INNOVASIS, INC.
Ethos Spinal System2010-12-07
INNOVASIS, INC.
Excella III-D2010-12-07
INNOVASIS, INC.
Excella II Spinal System2010-12-07
INNOVASIS, INC.
Ethos Spinal System2010-12-07
INNOVASIS, INC.
Excella III-D2010-12-07
INNOVASIS, INC.
Excella II Spinal System2010-12-07
INNOVASIS, INC.
Ethos Spinal System2010-12-07
INNOVASIS, INC.
EXCELLA II SPINAL SYSTEM MODEL EC2-002010-10-07
INNOVASIS, INC.
Excella2007-12-12
INNOVASIS, INC.
Excella-P2007-12-12
INNOVASIS, INC.
Ethos Spinal System2007-12-12
INNOVASIS, INC.
Excella2007-12-12
INNOVASIS, INC.
Excella-P2007-12-12
INNOVASIS, INC.
Ethos Spinal System2007-12-12
INNOVASIS, INC.
Excella2007-12-12
INNOVASIS, INC.
Excella-P2007-12-12
INNOVASIS, INC.
Ethos Spinal System2007-12-12
INNOVASIS, INC.
Excella2007-12-12
INNOVASIS, INC.
Excella-P2007-12-12
INNOVASIS, INC.
Ethos Spinal System2007-12-12
INNOVASIS, INC.
X-Box2007-12-12
INNOVASIS, INC.
X-Box RN2007-12-12
INNOVASIS, INC.
X-Box ARN2007-12-12
INNOVASIS, INC.
T-Box2007-12-12
INNOVASIS, INC.
Spacer PEEK VBR System2007-12-12
INNOVASIS, INC.
Box PEEK VBR System2007-12-12
INNOVASIS, INC.
Excella-M2007-12-12
INNOVASIS, INC.
Excella-M2007-12-12
INNOVASIS, INC.
Excella-M2007-12-12
INNOVASIS, INC.
Excella-M2007-12-12
INNOVASIS, INC.
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)2007-11-16
INNOVASIS, INC.
BOX PEEK VBR SYSTEM2006-12-22
INNOVASIS, INC.
OPTERYX CERVICAL PLATE SYSTEM2006-07-14
INNOVASIS, INC.
Ethos Anterior Cervical Fixation System2006-07-14
INNOVASIS, INC.
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM2006-06-30
INNOVASIS, INC.
EXCELLA-M SPINAL SYSTEM2004-10-07
INNOVASIS, INC.
PEEK CEMENT RESTRICTOR X-BOX2004-07-22

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