ClearanceBrief
Company · US

Innovasis, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2025. Name variants (Inc, Corp, punctuation) are merged.

35510(k) clearances (0 in 12 months)
7recalls (1 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
MAXIntervertebral Fusion Device With Bone Graft, Lumbar8
NKBThoracolumbosacral Pedicle Screw System8
KWQAppliance, Fixation, Spinal Intervertebral Body5
ODPIntervertebral Fusion Device With Bone Graft, Cervical5
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar4
OLOOrthopedic Stereotaxic Instrument3
FSTLight, Surgical, Fiberoptic1
GWOPlate, Cranioplasty, Preformed, Alterable1
JDKProsthesis, Hip, Cement Restrictor1
KWPAppliance, Fixation, Spinal Interlaminal1
MNHOrthosis, Spondylolisthesis Spinal Fixation1
MQPSpinal Vertebral Body Replacement Device1
NKGPosterior Cervical Screw System1
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1
PEKSpinous Process Plate1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 25, 2025K250076Endeavor™ Stand-Alone Cervical IBF System
Innovasis
OVE
Jul 23, 2025K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
Innovasis, Inc.
OLO
Mar 24, 2025K250603AxTiHA® Stand-Alone ALIF System
Innovasis
OVD
Mar 24, 2025K250182Innovasis Navigation Instruments
Innovasis, Inc.
OLO
May 20, 2024K241276Vector™ Pedicle Screw System
Innovasis, Inc.
NKB
Oct 17, 2023K231899HAtetracell™-C Titanium Cervical IBF System
Innovasis, Inc.
ODP
May 2, 2023K223511Excella Navigation Instruments
Innovasis, Inc.
OLO
Dec 12, 2022K223510Matrix HA Fusion Porous Cervical IBF System
Innovasis, Inc.
ODP
Aug 26, 2022K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
Innovasis, Inc.
ODP
Oct 15, 2021K212967AxTiHA Stand-Alone ALIF System
Innovasis, Inc.
OVD
Jul 15, 2020K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
Innovasis, Inc.
MAX
Jun 30, 2020K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
Innovasis, Inc.
FST
Nov 8, 2019K192049Oryx Cervical Plate System
Innovasis, Inc.
KWQ
Sep 24, 2019K192354Innovasis Gibralt Spine System
Innovasis, Inc.
NKG
Jun 28, 2019K183064TxTi IBF System
Innovasis, Inc.
MAX
Jun 21, 2019K182139AXTi Titanium Stand-Alone ALIF System
Innovasis, Inc.
OVD
Jun 17, 2019K190684LxHA PEEK Lateral IBF System
Innovasis, Inc.
MAX
Jul 16, 2018K181115CxHA PEEK Cervical IBF System
Innovasis, Inc.
ODP
Jul 13, 2018K181063Kestrel™ Buttress Plate System
Innovasis, Inc.
KWQ
Apr 17, 2018K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Innovasis, Inc.
MAX
Apr 20, 2017K162236Ax Stand-Alone ALIF System
Innovasis, Inc.
OVD
Sep 23, 2016K162143FixxSure® X-Link
Innovasis, Inc.
MNH
Oct 14, 2015K151785Px HA PEEK IBF System
Innovasis, Inc.
MAX
Jun 19, 2015K150500Px PEEK IBF System
Innovasis, Inc.
MAX
Nov 7, 2014K141644INNOVASIS CRANIAL SYSTEM
Innovasis, Inc.
GWO
Jul 14, 2014K132765PFX SPINOUS PROCESS FIXATION SYSTEM
Innovasis, Inc.
PEK
May 7, 2014K140238EXCELLA III-D SPINAL DEFORMITY SYSTEM
Innovasis, Inc.
NKB
Feb 12, 2014K132991C-BOX PEEK CERVICAL IBF
Innovasis, Inc.
ODP
Oct 17, 2012K121581BOX PEEK VBR SYSTEM,
Innovasis, Inc.
MAX
Oct 7, 2010K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00
Innovasis, Inc.
NKB
Nov 16, 2007K071921INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
Innovasis, Inc.
NKB
Dec 22, 2006K062151BOX PEEK VBR SYSTEM
Innovasis, Inc.
MQP
Jun 30, 2006K061147OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
Innovasis, Inc.
KWQ
Oct 7, 2004K042143EXCELLA-M SPINAL SYSTEM
Innovasis, Inc.
KWP
Jul 22, 2004K041583PEEK CEMENT RESTRICTOR X-BOX
Innovasis, Inc.
JDK

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 3, 2026Innovasis, Inc
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Open, Classified		 NKBK241276
K250182 +1
Sep 17, 2024Innovasis, Inc
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone gr
Open, Classified		 MAXK180078
K183064 +1
Apr 7, 2020Innovasis, Inc
Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
Terminated		 KWQK192049
Jan 8, 2018Innovasis, Inc
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in
Terminated		 NKBK102248
May 23, 2017Innovasis, Inc
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. T
Terminated		 KWQK061147
Jan 19, 2016Innovasis, Inc
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization
Terminated		 NKBK102248
K140238
Jul 16, 2014Innovasis, Inc
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as
Terminated		 NKBK102248
K140238
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