Innovasis, Inc

FDA Filings

This page includes the latest FDA filings for Innovasis, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

Manufacturer	Device Name	Date
K192049 Innovasis, Inc.	Oryx Cervical Plate System	2019-11-08
K192354 Innovasis, Inc.	Innovasis Gibralt Spine System	2019-09-24
K183064 Innovasis, Inc.	TxTi IBF System	2019-06-28
K182139 Innovasis, Inc.	AXTi Titanium Stand-Alone ALIF System	2019-06-21
K190684 Innovasis, Inc.	LxHA PEEK Lateral IBF System	2019-06-17
K181115 Innovasis, Inc.	CxHA PEEK Cervical IBF System	2018-07-16
K181063 Innovasis, Inc.	Kestrel™ Buttress Plate System	2018-07-13
K180078 Innovasis, Inc.	Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System	2018-04-17
K162236 INNOVASIS, INC.	Ax Stand-Alone ALIF System	2017-04-20
K151785 INNOVASIS, INC.	Px HA PEEK IBF System	2015-10-14
K150500 INNOVASIS, INC.	Px PEEK IBF System	2015-06-19
K121581 INNOVASIS, INC.	BOX PEEK VBR SYSTEM,	2012-10-17
K062151 INNOVASIS, INC.	BOX PEEK VBR SYSTEM	2006-12-22
K061147 INNOVASIS, INC.	OPTERYX ANTERIOR CERVICAL PLATE SYSTEM	2006-06-30

Latest Premarket Applications

PMA	Manufacturer	Device Name	Date

Latest De Novo Filings

De Novo	Manufacturer	Device Name	Date

GUDID Registrations

Device GUDID Device Name	Manufacturer	Date
M711LCR200 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR190 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR180 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR170 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR160 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR150 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR140 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR130 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR120 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR110 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR100 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR090 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR080 T-Box®	Innovasis, Inc.	2019-05-07
M711LCR070 T-Box®	Innovasis, Inc.	2019-05-07
M711LB1060 L-Box®	Innovasis, Inc.	2019-05-07
M711LB1050 L-Box®	Innovasis, Inc.	2019-05-07
M711LB1040 L-Box®	Innovasis, Inc.	2019-05-07
M711LB1010 L-Box®	Innovasis, Inc.	2019-05-07
M711LB1000 L-Box®	Innovasis, Inc.	2019-05-07
M711LB0990 L-Box®	Innovasis, Inc.	2019-05-07
M711LB0980 L-Box®	Innovasis, Inc.	2019-05-07
M711LB0970 L-Box®	Innovasis, Inc.	2019-05-07
M711LB0960 L-Box®	Innovasis, Inc.	2019-05-07
M711LS4340 Kestrel®	Innovasis, Inc.	2019-04-23
M711LS1810 Px®	Innovasis, Inc.	2019-04-23
M711LS1000 T-Box®	Innovasis, Inc.	2019-04-23
M711LCI010 X-Box	Innovasis, Inc.	2019-04-23
M711LB0100 L-Box®	Innovasis, Inc.	2019-04-23
M711CI0600 Opteryx®	Innovasis, Inc.	2019-04-23
M711HA12163000 PxHA®	Innovasis, Inc.	2019-04-15
M711HA12162800 PxHA®	Innovasis, Inc.	2019-04-15
M711HA12153200 PxHA®	Innovasis, Inc.	2019-04-15
M711HA12153000 PxHA®	Innovasis, Inc.	2019-04-15
M711HA12152800 PxHA­®	Innovasis, Inc.	2019-04-15
M711HA12143200 PxHA®	Innovasis, Inc.	2019-04-15