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.
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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