FDA 510(k) Applications Submitted by Innovasis, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K041583 |
06/11/2004 |
PEEK CEMENT RESTRICTOR X-BOX |
INNOVASIS, INC. |
| K042143 |
08/09/2004 |
EXCELLA-M SPINAL SYSTEM |
INNOVASIS, INC. |
| K061147 |
04/25/2006 |
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM |
INNOVASIS, INC. |
| K192354 |
08/29/2019 |
Innovasis Gibralt Spine System |
Innovasis, Inc. |
| K180078 |
01/10/2018 |
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System |
Innovasis, Inc. |
| K150500 |
02/26/2015 |
Px PEEK IBF System |
INNOVASIS, INC. |
| K190684 |
03/18/2019 |
LxHA PEEK Lateral IBF System |
Innovasis, Inc. |
| K220875 |
03/25/2022 |
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System |
Innovasis, Inc. |
| K200874 |
04/01/2020 |
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End |
Innovasis, Inc. |
| K181063 |
04/23/2018 |
KestrelÖ Buttress Plate System |
Innovasis, Inc. |
| K181115 |
04/27/2018 |
CxHA PEEK Cervical IBF System |
Innovasis, Inc. |
| K201614 |
06/15/2020 |
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System |
Innovasis, Inc. |
| K141644 |
06/19/2014 |
INNOVASIS CRANIAL SYSTEM |
INNOVASIS, INC. |
| K151785 |
07/01/2015 |
Px HA PEEK IBF System |
INNOVASIS, INC. |
| K192049 |
07/31/2019 |
Oryx Cervical Plate System |
Innovasis, Inc. |
| K162143 |
08/01/2016 |
FixxSure« X-Link |
INNOVASIS, INC. |
| K182139 |
08/07/2018 |
AXTi Titanium Stand-Alone ALIF System |
Innovasis, Inc. |
| K162236 |
08/09/2016 |
Ax Stand-Alone ALIF System |
INNOVASIS, INC. |
| K132765 |
09/04/2013 |
PFX SPINOUS PROCESS FIXATION SYSTEM |
INNOVASIS, INC. |
| K212967 |
09/16/2021 |
AxTiHA Stand-Alone ALIF System |
Innovasis, Inc. |
| K132991 |
09/24/2013 |
C-BOX PEEK CERVICAL IBF |
INNOVASIS, INC. |
| K183064 |
11/05/2018 |
TxTi IBF System |
Innovasis, Inc. |
| K121581 |
05/30/2012 |
BOX PEEK VBR SYSTEM, |
INNOVASIS, INC. |
| K102248 |
08/09/2010 |
EXCELLA II SPINAL SYSTEM MODEL EC2-00 |
INNOVASIS, INC. |
| K140238 |
01/30/2014 |
EXCELLA III-D SPINAL DEFORMITY SYSTEM |
INNOVASIS, INC. |
| K250182 |
01/22/2025 |
Innovasis Navigation Instruments |
Innovasis, Inc. |
| K251073 |
04/08/2025 |
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) |
Innovasis, Inc. |
| K241276 |
05/06/2024 |
VectorÖ Pedicle Screw System |
Innovasis, Inc. |
| K231899 |
06/28/2023 |
HAtetracellÖ-C Titanium Cervical IBF System |
Innovasis, Inc. |
| K223510 |
11/22/2022 |
Matrix HA Fusion Porous Cervical IBF System |
Innovasis, Inc. |
| K223511 |
11/22/2022 |
Excella Navigation Instruments |
Innovasis, Inc. |
| K071921 |
07/12/2007 |
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) |
INNOVASIS, INC. |
| K062151 |
07/27/2006 |
BOX PEEK VBR SYSTEM |
INNOVASIS, INC. |
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