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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 a medical device manufactured by Axis Spine Technologies, Ltd.. It received FDA 510(k) clearance on 2021-09-29 under approval 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. It is manufactured by Axis Spine Technologies, Ltd.. The 510(k) number is K210590.

When was Axis Spine Technologies ALIF approved by the FDA?

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

What company makes Axis Spine Technologies ALIF?

Axis Spine Technologies ALIF is manufactured by Axis Spine Technologies, Ltd..

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

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

Related Clinical Trials

NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by Axis Spine Technologies, Ltd.

K200352Axis Spine Technologies ALIF

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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