Innovasis, Inc
Millcreek, UT, US
INNOVASIS, INC. appears in FDA device records in Millcreek, UT. FDA records list 35 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 35 510(k) clearances for Innovasis, Inc between 2004 and 2025. The busiest year on record is 2019, with 5. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 5 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | OVE | Substantially Equivalent | |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | OLO | Substantially Equivalent | |
| K250603 | AxTiHA® Stand-Alone ALIF System | OVD | Substantially Equivalent | |
| K250182 | Innovasis Navigation Instruments | OLO | Substantially Equivalent | |
| K241276 | Vector™ Pedicle Screw System | NKB | Substantially Equivalent | |
| K231899 | HAtetracell™-C Titanium Cervical IBF System | ODP | Substantially Equivalent | |
| K223511 | Excella Navigation Instruments | OLO | Substantially Equivalent | |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | ODP | Substantially Equivalent | |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | ODP | Substantially Equivalent | |
| K212967 | AxTiHA Stand-Alone ALIF System | OVD | Substantially Equivalent | |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | MAX | Substantially Equivalent | |
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | FST | Substantially Equivalent | |
| K192049 | Oryx Cervical Plate System | KWQ | Substantially Equivalent | |
| K192354 | Innovasis Gibralt Spine System | NKG | Substantially Equivalent | |
| K183064 | TxTi IBF System | MAX | Substantially Equivalent | |
| K182139 | AXTi Titanium Stand-Alone ALIF System | OVD | Substantially Equivalent | |
| K190684 | LxHA PEEK Lateral IBF System | MAX | Substantially Equivalent | |
| K181115 | CxHA PEEK Cervical IBF System | ODP | Substantially Equivalent | |
| K181063 | Kestrel™ Buttress Plate System | KWQ | Substantially Equivalent | |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | MAX | Substantially Equivalent | |
| K162236 | Ax Stand-Alone ALIF System | OVD | Substantially Equivalent | |
| K162143 | FixxSure® X-Link | MNH | Substantially Equivalent | |
| K151785 | Px HA PEEK IBF System | MAX | Substantially Equivalent | |
| K150500 | Px PEEK IBF System | MAX | Substantially Equivalent | |
| K141644 | INNOVASIS CRANIAL SYSTEM | GWO | Substantially Equivalent | |
| K132765 | PFX SPINOUS PROCESS FIXATION SYSTEM | PEK | Substantially Equivalent | |
| K140238 | EXCELLA III-D SPINAL DEFORMITY SYSTEM | NKB | Substantially Equivalent | |
| K132991 | C-BOX PEEK CERVICAL IBF | ODP | Substantially Equivalent | |
| K121581 | BOX PEEK VBR SYSTEM, | MAX | Substantially Equivalent | |
| K102248 | EXCELLA II SPINAL SYSTEM MODEL EC2-00 | NKB | Substantially Equivalent | |
| K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) | NKB | Substantially Equivalent | |
| K062151 | BOX PEEK VBR SYSTEM | MQP | Substantially Equivalent | |
| K061147 | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K042143 | EXCELLA-M SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K041583 | PEEK CEMENT RESTRICTOR X-BOX | JDK | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004719693 | 3004719693 | INNOVASIS, INC. | 614 E 3900 S, Millcreek, UT 84107 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- GXRCover, Burr Hole
- HBWFastener, Plate, Cranioplasty
- HTZInstrument, Cutting, Orthopedic
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- FSTLight, Surgical, Fiberoptic
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GWOPlate, Cranioplasty, Preformed, Alterable
- NKGPosterior Cervical Screw System
- JDKProsthesis, Hip, Cement Restrictor
- GADRetractor
- MQPSpinal Vertebral Body Replacement Device
- PEKSpinous Process Plate
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2859-2026 | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step. | Class II | Open, Classified | |
| Z-3163-2024 | 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 graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. | Class II | Open, Classified | |
| Z-2062-2020 | 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. | Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw. | Class II | Terminated | |
| Z-0644-2018 | 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 treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine: | Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. | Class II | Terminated | |
| Z-2153-2017 | 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. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae. | Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). | Class II | Terminated | |
| Z-0662-2016 | 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 tray as implant set. Intended for use in the non-cervical area of the spine. | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. | Class II | Terminated | |
| Z-2067-2014 | 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 implant set. | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain