Data / Medical devices / United States / INNO Holdings Inc.
INNO Holdings Inc.: FDA-registered device maker in Millcreek, UT, United States, 35 510(k) clearances
INNO Holdings Inc. is registered with the FDA (registration 3004719693) in Millcreek, UT, United States. It lists 20 device types. The FDA files 35 510(k) clearances under its listings, the newest dated September 11, 2026. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004719693
- Address
- 614 E 3900 S, Millcreek, UT, United States, 84107
- Owner or operator
- Inno Holdings Inc. (10094493)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 3, 2025
- Registered through
- 2027
- Brand names listed
- A-Box PEEK IBF System, AxHA Stand-Alone ALIF System, AxTiHA Stand-Alone ALIF System, C-Box PEEK Cervical IBF System, CxHA PEEK Cervical IBF System, Endeavor Stand-Alone Cervical IBF System, Excella 3 Spinal System, Excella G-E Navigation Instruments and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | OVD | Substantially Equivalent | INNO Holdings Inc. DBA Innovasis | accessdata.fda.gov |
| September 25, 2025 | K250076 | Endeavor Stand-Alone Cervical IBF System | OVE | Substantially Equivalent | Innovasis | accessdata.fda.gov |
| July 23, 2025 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | OLO | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| March 24, 2025 | K250603 | AxTiHA® Stand-Alone ALIF System | OVD | Substantially Equivalent | Innovasis | accessdata.fda.gov |
| March 24, 2025 | K250182 | Innovasis Navigation Instruments | OLO | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| May 20, 2024 | K241276 | Vector Pedicle Screw System | NKB | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| October 17, 2023 | K231899 | HAtetracell-C Titanium Cervical IBF System | ODP | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| May 2, 2023 | K223511 | Excella Navigation Instruments | OLO | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| October 15, 2021 | K212967 | AxTiHA Stand-Alone ALIF System | OVD | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| July 15, 2020 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | MAX | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| June 30, 2020 | K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | FST | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| November 8, 2019 | K192049 | Oryx Cervical Plate System | KWQ | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| September 24, 2019 | K192354 | Innovasis Gibralt Spine System | NKG | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| June 17, 2019 | K190684 | LxHA PEEK Lateral IBF System | MAX | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| July 16, 2018 | K181115 | CxHA PEEK Cervical IBF System | ODP | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| July 13, 2018 | K181063 | Kestrel Buttress Plate System | KWQ | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| April 17, 2018 | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | MAX | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| April 20, 2017 | K162236 | Ax Stand-Alone ALIF System | OVD | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| September 23, 2016 | K162143 | FixxSure® X-Link | MNH | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| October 14, 2015 | K151785 | Px HA PEEK IBF System | MAX | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| June 19, 2015 | K150500 | Px PEEK IBF System | MAX | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| November 7, 2014 | K141644 | INNOVASIS CRANIAL SYSTEM | GWO | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| July 2, 2014 | K141452 | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW | GWO | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| May 7, 2014 | K140238 | EXCELLA III-D SPINAL DEFORMITY SYSTEM | NKB | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| April 11, 2014 | K133340 | SPINEWORKS ANTERIOR LUMBAR DEVICE | MAX | Substantially Equivalent | Spineworks, LLC | accessdata.fda.gov |
| February 12, 2014 | K132991 | C-BOX PEEK CERVICAL IBF | ODP | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| October 17, 2012 | K121581 | BOX PEEK VBR SYSTEM, | MAX | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| December 17, 2010 | K101563 | SMARTO | KIJ | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| October 7, 2010 | K102248 | EXCELLA II SPINAL SYSTEM MODEL EC2-00 | NKB | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| July 23, 2008 | K081331 | FIXXSURE CROSS LINK | MNH | Substantially Equivalent | Spineworks, LLC | accessdata.fda.gov |
| November 16, 2007 | K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) | NKB | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| December 22, 2006 | K062151 | BOX PEEK VBR SYSTEM | MQP | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| June 30, 2006 | K061147 | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
| February 18, 2005 | K042600 | STANSION MATRIX | MQP | Substantially Equivalent | Spineworks, LLC | accessdata.fda.gov |
| October 7, 2004 | K042143 | EXCELLA-M SPINAL SYSTEM | KWP | Substantially Equivalent | Innovasis, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | 99188 | Class II | Ongoing | 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 met | accessdata.fda.gov |
| August 14, 2024 | 95185 | Class II | Ongoing | 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 restri | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. | accessdata.fda.gov |
| April 7, 2020 | 85575 | Class II | Terminated | 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 | accessdata.fda.gov |
| January 8, 2018 | 78946 | Class II | Terminated | 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 fo | Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. | accessdata.fda.gov |
| May 5, 2017 | 77206 | Class II | Terminated | 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 Pl | Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). | accessdata.fda.gov |
| December 7, 2015 | 72878 | Class II | Terminated | 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. | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. | accessdata.fda.gov |
| July 7, 2014 | 68781 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
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- All makers of Orthopedic Stereotaxic Instrument
- All makers of Fastener, Plate, Cranioplasty
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.