Innovasis, Inc.
Medical device manufacturer in Salt Lake City, UT.
35510(k) clearances
0PMA approvals
7recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 7
- ODP Intervertebral Fusion Device With Bone… 5
- NKB Thoracolumbosacral Pedicle Screw System 4
- OVD Intervertebral Fusion Device With… 4
- KWQ Appliance, Fixation, Spinal Intervertebral… 3
- OLO Orthopedic Stereotaxic Instrument 3
- JDK Prosthesis, Hip, Cement Restrictor 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- MQP Spinal Vertebral Body Replacement Device 1
- PEK Spinous Process Plate 1
- GWO Plate, Cranioplasty, Preformed, Alterable 1
- MNH Orthosis, Spondylolisthesis Spinal Fixation 1
- NKG Posterior Cervical Screw System 1
- FST Light, Surgical, Fiberoptic 1
- OVE Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250076 | Endeavor Stand-Alone Cervical IBF SystemOVE · Traditional | 09/25/2025SE |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…OLO · Traditional | 07/23/2025SE |
| K250603 | AxTiHA® Stand-Alone ALIF SystemOVD · Special | 03/24/2025SE |
| K250182 | Innovasis Navigation InstrumentsOLO · Traditional | 03/24/2025SE |
| K241276 | Vector Pedicle Screw SystemNKB · Traditional | 05/20/2024SE |
| K231899 | HAtetracell-C Titanium Cervical IBF SystemODP · Traditional | 10/17/2023SE |
| K223511 | Excella Navigation InstrumentsOLO · Traditional | 05/02/2023SE |
| K223510 | Matrix HA Fusion Porous Cervical IBF SystemODP · Special | 12/12/2022SE |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP · Traditional | 08/26/2022SE |
| K212967 | AxTiHA Stand-Alone ALIF SystemOVD · Special | 10/15/2021SE |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemMAX · Special | 07/15/2020SE |
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With…FST · Traditional | 06/30/2020SE |
| K192049 | Oryx Cervical Plate SystemKWQ · Traditional | 11/08/2019SE |
| K192354 | Innovasis Gibralt Spine SystemNKG · Special | 09/24/2019SE |
| K183064 | TxTi IBF SystemMAX · Traditional | 06/28/2019SE |
| K182139 | AXTi Titanium Stand-Alone ALIF SystemOVD · Traditional | 06/21/2019SE |
| K190684 | LxHA PEEK Lateral IBF SystemMAX · Traditional | 06/17/2019SE |
| K181115 | CxHA PEEK Cervical IBF SystemODP · Traditional | 07/16/2018SE |
| K181063 | Kestrel Buttress Plate SystemKWQ · Traditional | 07/13/2018SE |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemMAX · Traditional | 04/17/2018SE |
| K162236 | Ax Stand-Alone ALIF SystemOVD · Traditional | 04/20/2017SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | 09/23/2016SE |
| K151785 | Px HA PEEK IBF SystemMAX · Traditional | 10/14/2015SE |
| K150500 | Px PEEK IBF SystemMAX · Traditional | 06/19/2015SE |
| K141644 | Innovasis Cranial SystemGWO · Traditional | 11/07/2014SE |
| K132765 | PFX Spinous Process Fixation SystemPEK · Traditional | 07/14/2014SE |
| K140238 | Excella Iii-D Spinal Deformity SystemNKB · Traditional | 05/07/2014SE |
| K132991 | C-Box PEEK Cervical IbfODP · Traditional | 02/12/2014SE |
| K121581 | Box PEEK VBR System,MAX · Traditional | 10/17/2012SE |
| K102248 | Excella II Spinal System Model EC2-00NKB · Special | 10/07/2010SE |
| K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…NKB · Special | 11/16/2007SE |
| K062151 | Box PEEK VBR SystemMQP · Traditional | 12/22/2006SE |
| K061147 | Opteryx Anterior Cervical Plate SystemKWQ · Traditional | 06/30/2006SE |
| K042143 | Excella-M Spinal SystemKWP · Traditional | 10/07/2004SE |
| K041583 | PEEK Cement Restrictor X-BoxJDK · Traditional | 07/22/2004SESU |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2859-2026 Class II | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw SystemPedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to… | 05/22/2026Open, Classified |
| Z-3163-2024 Class II | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System…Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. | 08/14/2024Open, Classified |
| Z-2062-2020 Class II | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate…Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The… | 04/07/2020Terminated |
| Z-0644-2018 Class II | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature…Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. | 01/08/2018Terminated |
| Z-2153-2017 Class II | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged…Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). | 05/05/2017Terminated |
| Z-0662-2016 Class II | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR…Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. | 12/07/2015Terminated |
| Z-2067-2014 Class II | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm.…Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog… | 07/07/2014Terminated |