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FDA 510(k)

Cervical Spine Truss System Plating Solution (CSTS-PS)

K-Number: K212527 · 2022-05-17

Applicant4Web Medical, Inc.
Decision Date2022-05-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Spine Truss System Plating Solution (CSTS-PS) is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2022-05-17 under approval number K212527. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervical Spine Truss System Plating Solution (CSTS-PS)?

Cervical Spine Truss System Plating Solution (CSTS-PS) is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K212527.

When was Cervical Spine Truss System Plating Solution (CSTS-PS) approved by the FDA?

Cervical Spine Truss System Plating Solution (CSTS-PS) received FDA 510(k) clearance on 2022-05-17, under approval number K212527.

What company makes Cervical Spine Truss System Plating Solution (CSTS-PS)?

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

What is the FDA product code for Cervical Spine Truss System Plating Solution (CSTS-PS)?

The FDA product code for Cervical Spine Truss System Plating Solution (CSTS-PS) is KWQ.

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by 4Web Medical, Inc.

K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device K221283Hammertoe Truss System (HTS) K220463Osteotomy Truss System (OTS) K231739Cervical Spine Truss System (CSTS) 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: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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