AxTiHA Stand-Alone ALIF System

Q: What is the product code of K212967?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K212967 · Innovasis, Inc.

Substantially Equivalent

510(k) numberK212967

Submission

Device name: AxTiHA Stand-Alone ALIF System
Applicant: Innovasis, Inc.
Salt Lake City, UT, US
Received: September 16, 2021
Decision date: October 15, 2021
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other 510(k)s with product code OVD

510(k)	Device	Applicant	Decision
K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261408	SABER-XA SystemOVD · Traditional	Elevation Spine	08/03/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE

More from Alphatec Spine

510(k)	Device	Decision
K250076	Endeavor Stand-Alone Cervical IBF SystemOVE · Traditional	09/25/2025SE
K251073	Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…OLO · Traditional	07/23/2025SE
K250603	AxTiHA® Stand-Alone ALIF SystemOVD · Special	03/24/2025SE
K250182	Innovasis Navigation InstrumentsOLO · Traditional	03/24/2025SE
K241276	Vector Pedicle Screw SystemNKB · Traditional	05/20/2024SE
K231899	HAtetracell-C Titanium Cervical IBF SystemODP · Traditional	10/17/2023SE
K223511	Excella Navigation InstrumentsOLO · Traditional	05/02/2023SE
K223510	Matrix HA Fusion Porous Cervical IBF SystemODP · Special	12/12/2022SE
K220875	HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP · Traditional	08/26/2022SE
K201614	TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemMAX · Special	07/15/2020SE

Questions and answers

When was AxTiHA Stand-Alone ALIF System cleared by the FDA?

AxTiHA Stand-Alone ALIF System (K212967) received a 510(k) decision of Substantially Equivalent on October 15, 2021, 29 days after the submission was received.

What is the product code of K212967?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.