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FDA 510(k)

Cervical Spine Truss System (CSTS)

K-Number: K231739 · 2023-09-25

Applicant4Web Medical, Inc.
Decision Date2023-09-25
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Spine Truss System (CSTS) is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2023-09-25 under approval number K231739. 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 2023-09-25. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K231739.

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

Cervical Spine Truss System (CSTS) received FDA 510(k) clearance on 2023-09-25, under approval number K231739.

What company makes Cervical Spine Truss System (CSTS)?

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

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, 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) K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device

View all 11 devices →

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.

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