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FDA 510(k)

Anterior Spine Truss System-Stand Alone (ASTS-SA)

K-Number: K233966 · 2024-04-22

Applicant4Web Medical, Inc.
Decision Date2024-04-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anterior Spine Truss System-Stand Alone (ASTS-SA) is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2024-04-22 under approval number K233966. 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 Anterior Spine Truss System-Stand Alone (ASTS-SA)?

Anterior Spine Truss System-Stand Alone (ASTS-SA) is a medical device that received FDA 510(k) clearance on 2024-04-22. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K233966.

When was Anterior Spine Truss System-Stand Alone (ASTS-SA) approved by the FDA?

Anterior Spine Truss System-Stand Alone (ASTS-SA) received FDA 510(k) clearance on 2024-04-22, under approval number K233966.

What company makes Anterior Spine Truss System-Stand Alone (ASTS-SA)?

Anterior Spine Truss System-Stand Alone (ASTS-SA) is manufactured by 4Web Medical, Inc..

What is the FDA product code for Anterior Spine Truss System-Stand Alone (ASTS-SA)?

The FDA product code for Anterior Spine Truss System-Stand Alone (ASTS-SA) is OVD.

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Other Devices by 4Web Medical, Inc.

K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device K221283Hammertoe Truss System (HTS) K220463Osteotomy Truss System (OTS) K212527Cervical Spine Truss System Plating Solution (CSTS-PS) K231739Cervical Spine Truss System (CSTS) K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

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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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