510(k) K212967

AxTiHA Stand-Alone ALIF System by Innovasis, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 15, 2021
Date Received: September 16, 2021
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

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 clearances by Innovasis, Inc.

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K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Exce (July 23, 2025)
K250182 — Innovasis Navigation Instruments (March 24, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)
K241276 — Vector Pedicle Screw System (May 20, 2024)
K231899 — HAtetracell-C Titanium Cervical IBF System (October 17, 2023)
K223511 — Excella Navigation Instruments (May 2, 2023)
K223510 — Matrix HA Fusion Porous Cervical IBF System (December 12, 2022)
K220875 — HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (August 26, 2022)
K201614 — TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (July 15, 2020)

Other clearances for product code OVD

K253559 — Ventana A Anterior Lumbar Interbody System (February 25, 2026)
K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb (September 3, 2025)
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)