INNOVASIS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004719693	3004719693	INNOVASIS, INC.	1	Y	2020-04-25	614 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 GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
M71165161812081	HAtetracell™-C - HAtetracell-C, 16L x 18W x 12H x 8° Ti 6Al 4V (ELI), HA	801-261-2236	info@innovasis.com
M71165161812121	HAtetracell™-C - HAtetracell-C, 16L x 18W x 12H x 12°, Ti 6Al 4V (ELI), HA	801-261-2236	info@innovasis.com

innovasis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
63509	1087397445	K192354	Innovasis Gibralt Spine System	NKG	2019-09-24
63509	1428289126	K191764	Inion BioRestore	MQV	2019-07-31
63509	1594478083	K190684	LxHA PEEK Lateral IBF System	MAX	2019-06-17
63509	1853101603	K183064	TxTi IBF System	MAX	2019-06-28
63509	1040504598	K182139	AXTi Titanium Stand-Alone ALIF System	OVD	2019-06-21
63509	2068851976	K181115	CxHA PEEK Cervical IBF System	ODP	2018-07-16
63509	1785088303	K181063	Kestrel™ Buttress Plate System	KWQ	2018-07-13
63509	1665236445	K180078	Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System	MAX	2018-04-17
63509	1136237750	K162236	Ax Stand-Alone ALIF System	OVD	2017-04-20
63509	1089300058	K162143	FixxSure® X-Link	MNH	2016-09-23
63509	1206321895	K160697	Gibralt® Spine System and Gibralt® Occipital Spine System	NKG	2016-06-28
63509	1350574965	K151785	Px HA PEEK IBF System	MAX	2015-10-14
63509	1833826069	K150500	Px PEEK IBF System	MAX	2015-06-19
63509	1786137912	K141644	INNOVASIS CRANIAL SYSTEM	GWO	2014-11-07
63509	1179593958	K141452	LEFORTE NEURO SYSTEM BONE PLATE AND SCREW	GWO	2014-07-02
63509	2009718701	K140238	EXCELLA III-D SPINAL DEFORMITY SYSTEM	NKB	2014-05-07
63509	2073294675	K133340	SPINEWORKS ANTERIOR LUMBAR DEVICE	MAX	2014-04-11
63509	1382396202	K132991	C-BOX PEEK CERVICAL IBF	ODP	2014-02-12
63509	1006340921	K121581	BOX PEEK VBR SYSTEM,	MAX	2012-10-17
63509	1116756775	K113728	SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY	MBP	2012-11-15
63509	2070957383	K110976	ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM	MQV	2011-05-03
63509	1410835371	K102248	EXCELLA II SPINAL SYSTEM MODEL EC2-00	NKB	2010-10-07
63509	1046004328	K101563	SMARTO	KIJ	2010-12-17
63509	1272938560	K091686	LEFORTE NEUROSYSTEM BONE SCREW	HWC	2009-11-13
63509	1085500781	K091679	LEFORTE SYSTEM BONE PLATE	JEY	2009-10-02
63509	1541230939	K090177	INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE	MQV	2009-02-20
63509	1742992644	K081331	FIXXSURE CROSS LINK	MNH	2008-07-23
63509	2066100413	K071921	INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)	NKB	2007-11-16
63509	1671511898	K062151	BOX PEEK VBR SYSTEM	MQP	2006-12-22
63509	1058030547	K061147	OPTERYX ANTERIOR CERVICAL PLATE SYSTEM	KWQ	2006-06-30
63509	1354106224	K042600	STANSION MATRIX	MQP	2005-02-18
63509	2039404131	K042143	EXCELLA-M SPINAL SYSTEM	KWP	2004-10-07
63509	1726945160
63509	2006398493

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MAX	7	2019-06-28
MQV	3	2019-07-31
NKB	3	2014-05-07
NKG	2	2019-09-24
OVD	2	2019-06-21
ODP	2	2018-07-16
KWQ	2	2018-07-13
MNH	2	2016-09-23
GWO	2	2014-11-07
MQP	2	2006-12-22
MBP	1	2012-11-15
KIJ	1	2010-12-17
HWC	1	2009-11-13
JEY	1	2009-10-02
KWP	1	2004-10-07

PMN#

Vector? Pedicle Screw System
2024-05-20
Innovasis, Inc.
HAtetracell?-C Titanium Cervical IBF System
2023-10-17
Innovasis, Inc.
Excella Navigation Instruments
2023-05-02
Innovasis, Inc.
Matrix HA Fusion Porous Cervical IBF System
2022-12-12
Innovasis, Inc.
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
2022-08-26
Innovasis, Inc.
AxTiHA Stand-Alone ALIF System
2021-10-15
Innovasis, Inc.
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
2020-07-15
Innovasis, Inc.
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
2020-06-30
Innovasis, Inc.
Oryx Cervical Plate System
2019-11-08
Innovasis, Inc.
Innovasis Gibralt Spine System
2019-09-24
Innovasis, Inc.
TxTi IBF System
2019-06-28
Innovasis, Inc.
AXTi Titanium Stand-Alone ALIF System
2019-06-21
Innovasis, Inc.
LxHA PEEK Lateral IBF System
2019-06-17
Innovasis, Inc.
CxHA PEEK Cervical IBF System
2018-07-16
Innovasis, Inc.
Kestrel™ Buttress Plate System
2018-07-13
Innovasis, Inc.
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
2018-04-17
Innovasis, Inc.
Ax Stand-Alone ALIF System
2017-04-20
INNOVASIS, INC.
FixxSure® X-Link
2016-09-23
INNOVASIS, INC.
Px HA PEEK IBF System
2015-10-14
INNOVASIS, INC.
Px PEEK IBF System
2015-06-19
INNOVASIS, INC.
INNOVASIS CRANIAL SYSTEM
2014-11-07
INNOVASIS, INC.
PFX SPINOUS PROCESS FIXATION SYSTEM
2014-07-14
INNOVASIS, INC.
EXCELLA III-D SPINAL DEFORMITY SYSTEM
2014-05-07
INNOVASIS, INC.
C-BOX PEEK CERVICAL IBF
2014-02-12
INNOVASIS, INC.
BOX PEEK VBR SYSTEM,
2012-10-17
INNOVASIS, INC.
EXCELLA II SPINAL SYSTEM MODEL EC2-00
2010-10-07
INNOVASIS, INC.
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
2007-11-16
INNOVASIS, INC.
BOX PEEK VBR SYSTEM
2006-12-22
INNOVASIS, INC.
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
2006-06-30
INNOVASIS, INC.
EXCELLA-M SPINAL SYSTEM
2004-10-07
INNOVASIS, INC.
PEEK CEMENT RESTRICTOR X-BOX
2004-07-22
INNOVASIS, INC.

GUDID#

HAtetracell™-C - HAtetracell-C, 16L x 18W x 12H x 8° Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-10-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 12H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 5H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 6H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 7H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 8H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 8H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 9H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 9H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 10H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 10H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 11H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 11H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 12H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 19W x 12H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-09-30
HAtetracell™-C - HAtetracell-C, 16L x 18W x 6H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 7H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 7H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 8H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 8H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 9H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 9H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 10H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 10H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 11H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 11H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 19W x 6H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 16L x 19W x 7H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-08-31
HAtetracell™-C - HAtetracell-C, 15L x 17W x 11H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-07-31
HAtetracell™-C - HAtetracell-C, 15L x 17W x 11H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-07-31
HAtetracell™-C - HAtetracell-C, 15L x 17W x 12H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-07-31
HAtetracell™-C - HAtetracell-C, 15L x 17W x 12H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-07-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 5H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-07-31
HAtetracell™-C - HAtetracell-C, 16L x 18W x 6H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-07-31
HAtetracell™-C - HAtetracell-C, 12L x 14W x 5H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-05-31
HAtetracell™-C - HAtetracell-C, 12L x 14W x 5H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-05-31
HAtetracell™-C - HAtetracell-C, 12L x 14W x 6H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-05-31
HAtetracell™-C - HAtetracell-C, 12L x 14W x 6H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-05-31
HAtetracell™-C - HAtetracell-C, 12L x 14W x 7H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-05-31
HAtetracell™-C - HAtetracell-C, 12L x 14W x 7H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
2024-05-31

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