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FDA 510(k)

Ankle Truss System (ATS)

K-Number: K230088 · 2024-03-21

Applicant4Web Medical, Inc.
Decision Date2024-03-21
Product CodeSAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ankle Truss System (ATS) is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2024-03-21 under approval number K230088. The device is classified under product code SAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ankle Truss System (ATS)?

Ankle Truss System (ATS) is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K230088.

When was Ankle Truss System (ATS) approved by the FDA?

Ankle Truss System (ATS) received FDA 510(k) clearance on 2024-03-21, under approval number K230088.

What company makes Ankle Truss System (ATS)?

Ankle Truss System (ATS) is manufactured by 4Web Medical, Inc..

What is the FDA product code for Ankle Truss System (ATS)?

The FDA product code for Ankle Truss System (ATS) is SAI.

Related Clinical Trials

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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: SAI)

K242356TIDAL Fusion Cage SystemRestor3D, 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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