510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K262025Substantially Equivalent

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

INNO Holdings Inc. DBA Innovasis, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(87 days to decision)
Product code
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
INNO Holdings Inc. DBA Innovasis 614 E 3900 S, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVD

Trailing 12 months
9 clearances under product code OVD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OVD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260