Innovasis AxTiHA® Stand-Alone ALIF System +2 more— 510(k) K262025
Substantially EquivalentINNO Holdings Inc. DBA Innovasis
FDA 510(k) clearance K262025 for Innovasis AxTiHA® Stand-Alone ALIF System +2 more, Substantially Equivalent on 2026-09-11. Applicant: INNO Holdings Inc. DBA Innovasis. Device class: 2.
Summary
This clearance covers three Innovasis spinal systems at once: the AxTiHA Stand-Alone ALIF System, the TxTiHA IBF System, and the HAtetracell-C Titanium Cervical IBF System. They're filed under OVD, lumbar intervertebral fusion devices with integrated fixation. The "TiHA" in the names suggests titanium with hydroxyapatite, though the record doesn't spell it out.
Class II, 21 CFR 888.3080. The Orthopedic panel reviewed it as a Traditional 510(k). One of the three is a cervical device even though OVD is a lumbar code. The record only lists a primary product code, and multi-system filings often span several.
INNO Holdings (doing business as Innovasis) filed from Salt Lake City, Utah. Review took 87 days (June 16 to September 11, 2026), fast for three spinal systems in one submission.
Clearance details
- Device name as filed
- Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System
- Applicant
- INNO Holdings Inc. DBA Innovasis
- Product code
- Code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code OVD
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.