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FDA 510(k)

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

K-Number: K190870 · 2019-08-12

Applicant4Web, Inc.
Decision Date2019-08-12
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Spinal Truss System-Stand Alone (CSTS-SA) is a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2019-08-12 under approval number K190870. 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 Spinal Truss System-Stand Alone (CSTS-SA)?

Cervical Spinal Truss System-Stand Alone (CSTS-SA) is a medical device that received FDA 510(k) clearance on 2019-08-12. It is manufactured by 4Web, Inc.. The 510(k) number is K190870.

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

Cervical Spinal Truss System-Stand Alone (CSTS-SA) received FDA 510(k) clearance on 2019-08-12, under approval number K190870.

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

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

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

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

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by 4Web, Inc.

K153436LATERAL Spine Truss System K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device K170851Anterior Spine Truss System (STS) Interbody Fusion Device K172294Osteotomy Truss System (OTS) K173159Cervical Spinal 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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