Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cervical Spine Truss System - Stand Alone (CSTS-SA)

K-Number: K253200 · 2025-12-11

Applicant4Web Medical, Inc.
Decision Date2025-12-11
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Spine Truss System - Stand Alone (CSTS-SA) is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2025-12-11 under approval number K253200. 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)?

Cervical Spine Truss System - Stand Alone (CSTS-SA) is a medical device that received FDA 510(k) clearance on 2025-12-11. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K253200.

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

Cervical Spine Truss System - Stand Alone (CSTS-SA) received FDA 510(k) clearance on 2025-12-11, under approval number K253200.

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

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

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

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

Related Clinical Trials

NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT07382674 Zesty Exercise System for Therapeutic Engagement RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING

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

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.

↑