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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 the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) 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. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K231739.

When did Cervical Spine Truss System (CSTS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Cervical Spine Truss System (CSTS)?

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 (CSTS)?

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

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)K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)K251117Cervical Spine Truss System (CSTS)K240388Osteotomy Truss System (OTS)K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)K230088Ankle Truss System (ATS)

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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