510(k) clearance

Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System

FDA 510(k) source

510(k) number

K262025

Applicant

INNO Holdings Inc. DBA Innovasis

Decision date

Sep 11, 2026

Date received

Jun 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OVD

Device type

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Device class

Class II

Regulation

21 CFR 888.3080

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Salt Lake City, UT, US