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Sign in to claim this brandInnovasis, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 614 E 3900 S, Millcreek, UT, 84107
- Website
- innovasis.com
- —
- —
- [email protected]
- Phone
- 801-261-2236
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004719693
- DUNS Number
- 156567492
Catalogue (2944)
Page 59 of 59| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Excella III-D® | E3U4030 | FDA UDI | Class II | Active |
| LxHA™ | LXL26164508 | FDA UDI | Class II | Active |
| LxHA™ | LXT26184012 | FDA UDI | Class II | Active |
| Excella MIS® | EM47540 | FDA UDI | Class II | Active |
| Px™ | X21213300 | FDA UDI | Class II | Active |
| Excella 3® | E37545 | FDA UDI | Class II | Active |
| Px™ | X20809225 | FDA UDI | Class II | Active |
| LxHA™ | LXT22143012 | FDA UDI | Class II | Active |
| Excella II® | E2S47535 | FDA UDI | Class II | Active |
| Innovasis Navigation Instruments | K250182 | FDA 510(k) | Class II | Active |
| Kestrel™ Buttress Plate System | K181063 | FDA 510(k) | Class II | Active |
| Ax Stand-Alone ALIF System | K162236 | FDA 510(k) | Class II | Active |
| C-Box Peek Cervical Ibf | K132991 | FDA 510(k) | Class II | Active |
| Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | K251073 | FDA 510(k) | Class II | Active |
| Innovasis Excella Spinal System, Excella-M (monoaxial Screws), Excella-P (polyaxial Screws) | K071921 | FDA 510(k) | Class II | Active |
| Opteryx Anterior Cervical Plate System | K061147 | FDA 510(k) | Class II | Active |
| Oryx Cervical Plate System | K192049 | FDA 510(k) | Class II | Active |
| Endeavor™ Stand-Alone Cervical IBF System | K250076 | FDA 510(k) | Class II | Active |
| Pfx Spinous Process Fixation System | K132765 | FDA 510(k) | Class II | Active |
| Matrix HA Fusion Porous Cervical IBF System | K223510 | FDA 510(k) | Class II | Active |
| Px PEEK IBF System | K150500 | FDA 510(k) | Class II | Active |
| Excella-M Spinal System | K042143 | FDA 510(k) | Class II | Active |
| HAtetracell™-C Titanium Cervical IBF System | K231899 | FDA 510(k) | Class II | Active |
| Excella Iii-D Spinal Deformity System | K140238 | FDA 510(k) | Class II | Active |
| Innovasis Gibralt Spine System | K192354 | FDA 510(k) | Class II | Active |
| Box Peek Vbr System | K062151 | FDA 510(k) | Class II | Active |
| Innovasis Cranial System | K141644 | FDA 510(k) | Class II | Active |
| TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | K201614 | FDA 510(k) | Class II | Active |
| Vector™ Pedicle Screw System | K241276 | FDA 510(k) | Class II | Active |
| Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | K180078 | FDA 510(k) | Class II | Active |
| LxHA PEEK Lateral IBF System | K190684 | FDA 510(k) | Class II | Active |
| Px HA PEEK IBF System | K151785 | FDA 510(k) | Class II | Active |
| AxTiHA® Stand-Alone ALIF System | K250603 | FDA 510(k) | Class II | Active |
| AXTi Titanium Stand-Alone ALIF System | K182139 | FDA 510(k) | Class II | Active |
| FixxSure® X-Link | K162143 | FDA 510(k) | Class II | Active |
| TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | K200874 | FDA 510(k) | Class II | Active |
| Box Peek Vbr System, | K121581 | FDA 510(k) | Class II | Active |
| Excella Ii Spinal System Model Ec2-00 | K102248 | FDA 510(k) | Class II | Active |
| Excella Navigation Instruments | K223511 | FDA 510(k) | Class II | Active |
| HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | K220875 | FDA 510(k) | Class II | Active |
| AxTiHA Stand-Alone ALIF System | K212967 | FDA 510(k) | Class II | Active |
| CxHA PEEK Cervical IBF System | K181115 | FDA 510(k) | Class II | Active |
| TxTi IBF System | K183064 | FDA 510(k) | Class II | Active |
| Peek Cement Restrictor X-Box | K041583 | FDA 510(k) | Class II | Active |
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 14, 2024 | Z-3163-2024 | — | open, classified | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
| Apr 7, 2020 | Z-2062-2020 | — | terminated | 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. |
| Jan 8, 2018 | Z-0644-2018 | — | terminated | Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. |
| May 5, 2017 | Z-2153-2017 | — | terminated | Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). |
| Dec 7, 2015 | Z-0662-2016 | — | terminated | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. |
| Jul 7, 2014 | Z-2067-2014 | — | terminated | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. |