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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 the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2025-12-11 under 510(k) 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. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K253200.

When did Cervical Spine Truss System - Stand Alone (CSTS-SA) receive FDA 510(k) clearance?

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

Who is the listed applicant for Cervical Spine Truss System - Stand Alone (CSTS-SA)?

The FDA 510(k) record lists 4Web Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT07259811Vertebral Augmentation Using VCFix Spinal System in Stand-alone ConfigurationACTIVE_NOT_RECRUITING

Other records listing 4Web Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252834Sacroiliac Joint Truss System (SJTS)K251117Cervical Spine Truss System (CSTS)K240388Osteotomy Truss System (OTS)K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)K230088Ankle Truss System (ATS)K231739Cervical Spine Truss System (CSTS)

View all 13 devices →

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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