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FDA 510(k)

AxTiHA Stand-Alone ALIF System

K-Number: K212967 · 2021-10-15

ApplicantInnovasis, Inc.
Decision Date2021-10-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AxTiHA Stand-Alone ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K212967. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AxTiHA Stand-Alone ALIF System?

AxTiHA Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Innovasis, Inc.. The 510(k) number is K212967.

When did AxTiHA Stand-Alone ALIF System receive FDA 510(k) clearance?

AxTiHA Stand-Alone ALIF System received FDA 510(k) clearance on 2021-10-15, under 510(k) number K212967.

Who is the listed applicant for AxTiHA Stand-Alone ALIF System?

The FDA 510(k) record lists Innovasis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AxTiHA Stand-Alone ALIF System?

The FDA product code for AxTiHA Stand-Alone ALIF System is OVD.

Other records listing Innovasis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250076Endeavor™ Stand-Alone Cervical IBF SystemK251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250603AxTiHA® Stand-Alone ALIF SystemK250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF System

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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