FDA 510(k) Applications Submitted by MARSHALL C MCCARTY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K960183 |
01/16/1996 |
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) |
SMITH KLINE DIAGNOSTICS, INC. |
| K961062 |
03/18/1996 |
FLEXSURE OBT |
SMITHKLINE DIAGNOSTICS, INC. |
| K121581 |
05/30/2012 |
BOX PEEK VBR SYSTEM, |
INNOVASIS, INC. |
| K102248 |
08/09/2010 |
EXCELLA II SPINAL SYSTEM MODEL EC2-00 |
INNOVASIS, INC. |
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