Innovasis Inc FDA Filings

FDA Filings

Device Company	Device	Date
GUDID M711LB059160 Innovasis, Inc.	LxHA™ Angled Lateral	2025-09-08
GUDID M711LB059140 Innovasis, Inc.	LxHA™ Angled Lateral	2025-09-08
GUDID M711LB059120 Innovasis, Inc.	L-Box®	2025-07-08
GUDID M711LB059100 Innovasis, Inc.	L-Box®	2025-07-08
GUDID M711LB059080 Innovasis, Inc.	L-Box®	2025-07-08
GUDID M711LAA0700 Innovasis, Inc.	A-Box®	2025-07-08
GUDID M711LAA0600 Innovasis, Inc.	A-Box®	2025-07-08
GUDID M711LAA0550 Innovasis, Inc.	A-Box®	2025-07-08
GUDID M711LAA0500 Innovasis, Inc.	A-Box®	2025-07-08
GUDID M711LAA0300 Innovasis, Inc.	A-Box®	2025-07-08
GUDID M711LAA0100 Innovasis, Inc.	A-Box®	2025-07-08
GUDID M711LA1100 Innovasis, Inc.	T-Box®	2025-07-08
GUDID M711CR0120 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CR0110 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CR0100 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CR0090 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CR0080 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CR0070 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CR0060 Innovasis, Inc.	C-Box®	2025-07-08
GUDID M711CI1310 Innovasis, Inc.	Opteryx®	2025-07-08
GUDID M711CI0830 Innovasis, Inc.	Opteryx®	2025-06-09
GUDID M711CI0820 Innovasis, Inc.	Opteryx®	2025-06-09
GUDID M711CI0810 Innovasis, Inc.	Opteryx®	2025-06-09
GUDID M711CI0800 Innovasis, Inc.	Opteryx®	2025-06-09
GUDID M711CI0700 Innovasis, Inc.	Opteryx®	2025-06-09
GUDID M711CI0200 Innovasis, Inc.	Opteryx®	2025-06-09
GUDID M711CCT020 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCT010 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0140 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0130 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0120 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0110 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0100 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0090 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0080 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0070 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCS0060 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0120 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0110 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0100 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0090 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0080 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0070 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CCR0060 Innovasis, Inc.	C-Box®	2025-06-09
GUDID M711CC0110 Innovasis, Inc.	C-Box®	2025-05-08
GUDID M711CC0100 Innovasis, Inc.	C-Box®	2025-05-08
GUDID M711CC0090 Innovasis, Inc.	C-Box®	2025-05-08
GUDID M711BTA890 Innovasis, Inc.	Px®	2025-04-08
GUDID M711BTA830 Innovasis, Inc.	Excella III-D®	2025-04-08
GUDID M711BTA760 Innovasis, Inc.	Excella 3™	2025-04-08
GUDID M711CC0080 Innovasis, Inc.	C-Box®	2025-03-10
GUDID M711CC0070 Innovasis, Inc.	C-Box®	2025-03-10
GUDID M711CC0060 Innovasis, Inc.	C-Box®	2025-03-10
GUDID M711BTB010 Innovasis, Inc.	T-Box®	2025-03-10
GUDID M711BTA980 Innovasis, Inc.	Px®	2025-03-10
GUDID M711BTA960 Innovasis, Inc.	Innovasis® Disc Prep	2025-03-10
GUDID M711BTA950 Innovasis, Inc.	Px®	2025-03-10
GUDID M711BTA940 Innovasis, Inc.	Px®	2025-03-10
GUDID M711BTA930 Innovasis, Inc.	Px®	2025-03-10
GUDID M711BTA920 Innovasis, Inc.	Px®	2025-03-10
GUDID M711BTA910 Innovasis, Inc.	Px®	2025-03-10
GUDID M711PC1660 Innovasis, Inc.	Gibralt®	2025-02-10
GUDID M711PC1560 Innovasis, Inc.	Gibralt®	2025-02-10
GUDID M711PC1330 Innovasis, Inc.	Gibralt®	2025-02-10
GUDID M711PC1930 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1880 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1870 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1850 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1650 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1530 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1410 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1400 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711PC1190 Innovasis, Inc.	Gibralt®	2024-12-09
GUDID M711LS759050 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS759040 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS759030 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS759020 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS759010 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758270 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758260 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758250 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758240 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758230 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758220 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758200 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758190 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758180 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758120 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758110 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711LS758030 Innovasis, Inc.	HAtetracell™-C	2024-12-09
GUDID M711201160 Innovasis, Inc.	FixxSure	2024-12-09
GUDID M711LS758130 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758100 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758090 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758080 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758070 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758060 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758050 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M711LS758040 Innovasis, Inc.	HAtetracell™-C	2024-11-08
GUDID M71165161812081 Innovasis, Inc.	HAtetracell™-C	2024-11-08
PMN K220875 Innovasis, Inc.	HAcancellous PEEK-C Porous HA PEEK Cervical IBF System	2022-08-26
PMN K212967 Innovasis, Inc.	AxTiHA Stand-Alone ALIF System	2021-10-15
PMN K201614 Innovasis, Inc.	TxTiHA IBF System, AxTiHA Stand-Alone ALIF System	2020-07-15
PMN K200874 Innovasis, Inc.	TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End	2020-06-30
PMN K192049 Innovasis, Inc.	Oryx Cervical Plate System	2019-11-08
PMN K191764 \| MQV INNOVASIS, INC.	BioRestore	2019-11-08
PMN K192354 \| NKG INNOVASIS, INC.	Gibralt	2019-11-05
PMN K192354 \| KWP INNOVASIS, INC.	Gibralt	2019-11-05
PMN K192354 Innovasis, Inc.	Innovasis Gibralt Spine System	2019-09-24
PMN K183064 \| MAX INNOVASIS, INC.	TxTi?	2019-07-16
PMN K183064 Innovasis, Inc.	TxTi IBF System	2019-06-28
PMN K190684 \| MAX INNOVASIS, INC.	LxHA	2019-06-27
PMN K182139 \| OVD INNOVASIS, INC.	AXTi	2019-06-27
PMN K182139 Innovasis, Inc.	AXTi Titanium Stand-Alone ALIF System	2019-06-21
PMN K190684 Innovasis, Inc.	LxHA PEEK Lateral IBF System	2019-06-17
PMN K160697 \| NKG INNOVASIS, INC.	Gibralt Spine System	2018-08-30
PMN K160697 \| KWP INNOVASIS, INC.	Gibralt Spine System	2018-08-30
PMN K181115 \| ODP INNOVASIS, INC.	CxHA PEEK Cervical IBF System	2018-07-27
PMN K181115 \| ODP INNOVASIS, INC.	Cx Cervical IBF System	2018-07-27
PMN K181063 \| KWQ INNOVASIS, INC.	Kestrel Buttress Plate System	2018-07-27
PMN K181115 Innovasis, Inc.	CxHA PEEK Cervical IBF System	2018-07-16
PMN K181063 Innovasis, Inc.	Kestrel™ Buttress Plate System	2018-07-13
PMN K180078 \| MAX INNOVASIS, INC.	TxHA PEEK IBF System	2018-05-08
PMN K180078 \| MAX INNOVASIS, INC.	Px PEEK IBF System	2018-05-08
PMN K180078 \| MAX INNOVASIS, INC.	Px HA PEEK IBF System	2018-05-08
PMN K180078 Innovasis, Inc.	Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System	2018-04-17
PMN K141452 \| HBW INNOVASIS, INC.	Neuro & Craniofacial Fixation System	2017-06-08
PMN K141452 \| GXR INNOVASIS, INC.	Neuro & Craniofacial Fixation System	2017-06-08
PMN K141452 \| GWO INNOVASIS, INC.	Neuro & Craniofacial Fixation System	2017-06-08
PMN K101563 \| KIJ INNOVASIS, INC.	Neuro & Craniofacial Fixation System	2017-06-08
PMN K091686 \| HWC INNOVASIS, INC.	Neuro & Craniofacial Fixation System	2017-06-08
PMN K091679 \| JEY INNOVASIS, INC.	Neuro & Craniofacial Fixation System	2017-06-08
PMN K162236 INNOVASIS, INC.	Ax Stand-Alone ALIF System	2017-04-20
PMN K162236 \| OVD INNOVASIS, INC.	Ax Stand-Alone ALIF	2017-04-20
PMN K162143 \| MNI INNOVASIS, INC.	SpineWorks? FixxSure? X-Link	2016-10-07
PMN K162143 \| MNI INNOVASIS, INC.	FixxSure? X-Link	2016-10-07
PMN K162143 \| MNH INNOVASIS, INC.	SpineWorks? FixxSure? X-Link	2016-10-07
PMN K162143 \| MNH INNOVASIS, INC.	FixxSure? X-Link	2016-10-07
PMN K162143 INNOVASIS, INC.	FixxSure® X-Link	2016-09-23
PMN K151785 \| MAX INNOVASIS, INC.	Px HA PEEK IBF System	2015-11-25
PMN K151785 INNOVASIS, INC.	Px HA PEEK IBF System	2015-10-14
PMN K150500 \| MAX INNOVASIS, INC.	Px PEEK IBF System	2015-07-13
PMN K150500 INNOVASIS, INC.	Px PEEK IBF System	2015-06-19
PMN K133340 \| MAX INNOVASIS, INC.	SpineWorks ALD	2014-12-09
PMN K133340 \| MAX INNOVASIS, INC.	SW ALD	2014-12-09
PMN K081331 \| MNI INNOVASIS, INC.	FixxSure Crosslink	2014-12-09
PMN K081331 \| MNH INNOVASIS, INC.	FixxSure Crosslink	2014-12-09
PMN K042600 \| MQP INNOVASIS, INC.	Stansion Matrix	2014-12-09
LXH INNOVASIS, INC.	SpineWorks ALIF Instruments	2014-12-09
LXH INNOVASIS, INC.	Pedicle Subtraction Osteotomy Set	2014-12-09
HTZ INNOVASIS, INC.	Innovasis Disc Prep	2014-12-09
PMN K141644 \| HBW INNOVASIS, INC.	Innovasis Cranial System	2014-11-25
PMN K141644 \| GXR INNOVASIS, INC.	Innovasis Cranial System	2014-11-25
PMN K141644 \| GWO INNOVASIS, INC.	Innovasis Cranial System	2014-11-25
PMN K141644 INNOVASIS, INC.	INNOVASIS CRANIAL SYSTEM	2014-11-07
PMN K132765 INNOVASIS, INC.	PFX SPINOUS PROCESS FIXATION SYSTEM	2014-07-14
PMN K140238 \| NKB INNOVASIS, INC.	Excella III-D	2014-05-08
PMN K140238 \| MNI INNOVASIS, INC.	Excella III-D	2014-05-08
PMN K140238 \| MNH INNOVASIS, INC.	Excella III-D	2014-05-08
PMN K140238 \| KWQ INNOVASIS, INC.	Excella III-D	2014-05-08
PMN K140238 \| KWP INNOVASIS, INC.	Excella III-D	2014-05-08
PMN K140238 INNOVASIS, INC.	EXCELLA III-D SPINAL DEFORMITY SYSTEM	2014-05-07
PMN K132991 \| ODP INNOVASIS, INC.	C-Spacer	2014-02-26
PMN K132991 \| ODP INNOVASIS, INC.	C-Box	2014-02-26
PMN K132991 INNOVASIS, INC.	C-BOX PEEK CERVICAL IBF	2014-02-12
PMN K113728 \| MQV INNOVASIS, INC.	Innovasis DBM Putty	2013-11-22
PMN K113728 \| MBP INNOVASIS, INC.	Innovasis DBM Putty	2013-11-22
PMN K090177 \| MQV INNOVASIS, INC.	BioRestore	2013-11-22
PMN K121581 \| MAX INNOVASIS, INC.	Spacer Anterior Spinal System	2012-10-22
PMN K121581 \| MAX INNOVASIS, INC.	L-Box Lateral Spinal System	2012-10-22
PMN K121581 \| MAX INNOVASIS, INC.	L-Box IBF	2012-10-22
PMN K121581 \| MAX INNOVASIS, INC.	Box IBF	2012-10-22
PMN K121581 \| MAX INNOVASIS, INC.	Box IBF System	2012-10-22
PMN K121581 \| MAX INNOVASIS, INC.	A-Box IBF	2012-10-22
PMN K121581 \| MAX INNOVASIS, INC.	A-Box Anterior Spinal System	2012-10-22
PMN K110976 \| MQV INNOVASIS, INC.	Innovasis DBM Putty	2012-10-22
PMN K110976 \| MBP INNOVASIS, INC.	Innovasis DBM Putty	2012-10-22
PMN K121581 INNOVASIS, INC.	BOX PEEK VBR SYSTEM,	2012-10-17
PMN K102248 \| NKB INNOVASIS, INC.	Excella III-D	2010-12-07
PMN K102248 \| NKB INNOVASIS, INC.	Excella II Spinal System	2010-12-07
PMN K102248 \| NKB INNOVASIS, INC.	Ethos Spinal System	2010-12-07
PMN K102248 \| MNI INNOVASIS, INC.	Excella III-D	2010-12-07
PMN K102248 \| MNI INNOVASIS, INC.	Excella II Spinal System	2010-12-07
PMN K102248 \| MNI INNOVASIS, INC.	Ethos Spinal System	2010-12-07
PMN K102248 \| MNH INNOVASIS, INC.	Excella III-D	2010-12-07
PMN K102248 \| MNH INNOVASIS, INC.	Excella II Spinal System	2010-12-07
PMN K102248 \| MNH INNOVASIS, INC.	Ethos Spinal System	2010-12-07
PMN K102248 \| KWQ INNOVASIS, INC.	Excella III-D	2010-12-07
PMN K102248 \| KWQ INNOVASIS, INC.	Excella II Spinal System	2010-12-07
PMN K102248 \| KWQ INNOVASIS, INC.	Ethos Spinal System	2010-12-07
PMN K102248 \| KWP INNOVASIS, INC.	Excella III-D	2010-12-07
PMN K102248 \| KWP INNOVASIS, INC.	Excella II Spinal System	2010-12-07
PMN K102248 \| KWP INNOVASIS, INC.	Ethos Spinal System	2010-12-07
PMN K102248 INNOVASIS, INC.	EXCELLA II SPINAL SYSTEM MODEL EC2-00	2010-10-07
PMN K071921 \| NKB INNOVASIS, INC.	Excella	2007-12-12
PMN K071921 \| NKB INNOVASIS, INC.	Excella-P	2007-12-12
PMN K071921 \| NKB INNOVASIS, INC.	Ethos Spinal System	2007-12-12
PMN K071921 \| MNI INNOVASIS, INC.	Excella	2007-12-12
PMN K071921 \| MNI INNOVASIS, INC.	Excella-P	2007-12-12
PMN K071921 \| MNI INNOVASIS, INC.	Ethos Spinal System	2007-12-12
PMN K071921 \| MNH INNOVASIS, INC.	Excella	2007-12-12
PMN K071921 \| MNH INNOVASIS, INC.	Excella-P	2007-12-12
PMN K071921 \| MNH INNOVASIS, INC.	Ethos Spinal System	2007-12-12
PMN K071921 \| KWP INNOVASIS, INC.	Excella	2007-12-12
PMN K071921 \| KWP INNOVASIS, INC.	Excella-P	2007-12-12
PMN K071921 \| KWP INNOVASIS, INC.	Ethos Spinal System	2007-12-12
PMN K062151 \| MQP INNOVASIS, INC.	X-Box	2007-12-12
PMN K062151 \| MQP INNOVASIS, INC.	X-Box RN	2007-12-12
PMN K062151 \| MQP INNOVASIS, INC.	X-Box ARN	2007-12-12
PMN K062151 \| MQP INNOVASIS, INC.	T-Box	2007-12-12
PMN K062151 \| MQP INNOVASIS, INC.	Spacer PEEK VBR System	2007-12-12
PMN K062151 \| MQP INNOVASIS, INC.	Box PEEK VBR System	2007-12-12
PMN K042143 \| MNI INNOVASIS, INC.	Excella-M	2007-12-12
PMN K042143 \| MNH INNOVASIS, INC.	Excella-M	2007-12-12
PMN K042143 \| KWQ INNOVASIS, INC.	Excella-M	2007-12-12
PMN K042143 \| KWP INNOVASIS, INC.	Excella-M	2007-12-12
PMN K071921 INNOVASIS, INC.	INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)	2007-11-16
PMN K062151 INNOVASIS, INC.	BOX PEEK VBR SYSTEM	2006-12-22
PMN K061147 \| KWQ INNOVASIS, INC.	OPTERYX CERVICAL PLATE SYSTEM	2006-07-14
PMN K061147 \| KWQ INNOVASIS, INC.	Ethos Anterior Cervical Fixation System	2006-07-14
PMN K061147 INNOVASIS, INC.	OPTERYX ANTERIOR CERVICAL PLATE SYSTEM	2006-06-30
PMN K042143 INNOVASIS, INC.	EXCELLA-M SPINAL SYSTEM	2004-10-07
PMN K041583 INNOVASIS, INC.	PEEK CEMENT RESTRICTOR X-BOX	2004-07-22

Registration Number	3004719693
FEI Number	3004719693
Name	INNOVASIS, INC.
Owner & Operator	INNOVASIS, INC.
Contact Address	614 EAST 3900 SOUTH -- Salt Lake City UT 84107 US
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	614 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

NCAGE Code	5HSW7	INNOVASIS, INC.
CAGE Code	5HSW7	INNOVASIS, INC.
S.A.M. Registration	5HSW7 [156567492]	INNOVASIS, INC.