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FDA 510(k)

Axis Spine Technologies ALIF

K-Number: K210590 · 2021-09-29

ApplicantAxis Spine Technologies, Ltd.
Decision Date2021-09-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Axis Spine Technologies ALIF is the device name listed in this FDA 510(k) record. The listed applicant is Axis Spine Technologies, Ltd.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K210590. 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 Axis Spine Technologies ALIF?

Axis Spine Technologies ALIF is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Axis Spine Technologies, Ltd.. The 510(k) number is K210590.

When did Axis Spine Technologies ALIF receive FDA 510(k) clearance?

Axis Spine Technologies ALIF received FDA 510(k) clearance on 2021-09-29, under 510(k) number K210590.

Who is the listed applicant for Axis Spine Technologies ALIF?

The FDA 510(k) record lists Axis Spine Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axis Spine Technologies ALIF?

The FDA product code for Axis Spine Technologies ALIF is OVD.

Other records listing Axis Spine Technologies, Ltd. 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.

K200352Axis Spine Technologies ALIF

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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