FDA 510(k)

Cervical Spine Truss System (CSTS)

K-Number: K251117 · 2025-04-25

Decision Date2025-04-25

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cervical Spine Truss System (CSTS) is a medical device manufactured by 4Web Medical. It received FDA 510(k) clearance on 2025-04-25 under approval number K251117. 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 (CSTS)?

Cervical Spine Truss System (CSTS) is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by 4Web Medical. The 510(k) number is K251117.

When was Cervical Spine Truss System (CSTS) approved by the FDA?

Cervical Spine Truss System (CSTS) received FDA 510(k) clearance on 2025-04-25, under approval number K251117.

What company makes Cervical Spine Truss System (CSTS)?

Cervical Spine Truss System (CSTS) is manufactured by 4Web Medical.

What is the FDA product code for Cervical Spine Truss System (CSTS)?

The FDA product code for Cervical Spine Truss System (CSTS) is OVE.

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Other Devices by 4Web Medical

K252834Sacroiliac Joint Truss System (SJTS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.