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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 4 of 59| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AxTiHA® | AXTi103014 | FDA UDI | Class II | Active |
| Excella®-M | 0005535 | FDA UDI | Class II | Active |
| Ax® | BTA-125 | FDA UDI | Class I | Active |
| Gibralt® | 05-000-20-4020 | FDA UDI | Class II | Active |
| Excella 3® | E36560 | FDA UDI | Class II | Active |
| PxHA® | HA1211280 | FDA UDI | Class II | Active |
| C-Box® | BCC-03 | FDA UDI | Class I | Active |
| X-Box | 8101022 | FDA UDI | Class II | Active |
| L-Box® | LB-156 | FDA UDI | Class II | Active |
| Gibralt® | 05-002-10-3508 | FDA UDI | Class II | Active |
| FixxSure® | 5523 | FDA UDI | Class II | Active |
| Excella II® | PR5535 | FDA UDI | Class II | Active |
| Px® | LS-210-14 | FDA UDI | Class I | Active |
| Excella III-D® | LS-274 | FDA UDI | Class II | Active |
| Px™ | X21213280 | FDA UDI | Class II | Active |
| HAcancellous™ PEEK-C | 59-141606 | FDA UDI | Class II | Active |
| HAtetracell™-C | 65-16181208 | FDA UDI | Class II | Active |
| Ax® | LS-313 | FDA UDI | Class II | Active |
| LxHA™ | LXL26185512 | FDA UDI | Class II | Active |
| Ax® | LS-335 | FDA UDI | Class I | Active |
| HAtetracell™-C | 65-12140708 | FDA UDI | Class II | Active |
| Px™ | X21216320 | FDA UDI | Class II | Active |
| HAcancellous™ PEEK-C | 59-121411 | FDA UDI | Class II | Active |
| LxHA™ | LXL22165516 | FDA UDI | Class II | Active |
| L-Box® | XLB501400 | FDA UDI | Class II | Active |
| Excella III-D® | E3HP990 | FDA UDI | Class II | Active |
| L-Box® | XLB451212 | FDA UDI | Class II | Active |
| PxHA® | HA1015225 | FDA UDI | Class II | Active |
| Stansion Matrix® | C081007 | FDA UDI | Class II | Active |
| LxHA™ | BTA-170 | FDA UDI | Class II | Active |
| Excella MIS® | EM5530 | FDA UDI | Class II | Active |
| Excella MIS® | EM5545 | FDA UDI | Class II | Active |
| PxHA® | HA1214300 | FDA UDI | Class II | Active |
| LxHA™ | LXL18125508 | FDA UDI | Class II | Active |
| X-Box | LCS-09 | FDA UDI | Class I | Active |
| Px™ | X21014320 | FDA UDI | Class II | Active |
| Excella®-M | LA-T80 | FDA UDI | Class I | Active |
| Neuro & Craniofacial Fixation System | BTA-134 | FDA UDI | Class I | Active |
| CxHA™ | LS-458-02 | FDA UDI | Class II | Active |
| Excella MIS® | EM5525 | FDA UDI | Class II | Active |
| L-Box® | XLC450800 | FDA UDI | Class II | Active |
| Excella III-D® | E3S6560 | FDA UDI | Class II | Active |
| Innovasis® Disc Prep | BTA-96 | FDA UDI | Class I | Active |
| A-Box® | AB182806 | FDA UDI | Class II | Active |
| X-Box | LCS-10 | FDA UDI | Class I | Active |
| Gibralt® | 05-004-06-3560 | FDA UDI | Class II | Active |
| L-Box® | XLC501412 | FDA UDI | Class II | Active |
| Excella 3™ | E3N47540 | FDA UDI | Class II | Active |
| LxHA™ | LS-506-13 | FDA UDI | Class II | Active |
| AxHA® | AX163608 | FDA UDI | Class II | Active |
Related Companies
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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. |