FDA 510(k)

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

K-Number: K223362 · 2023-02-02

Decision Date2023-02-02

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2023-02-02 under approval number K223362. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device?

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K223362.

When was Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device approved by the FDA?

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device received FDA 510(k) clearance on 2023-02-02, under approval number K223362.

What company makes Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device?

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is manufactured by 4Web Medical, Inc..

What is the FDA product code for Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device?

The FDA product code for Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is OVE.

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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) K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.