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FDA 510(k)

CBT Screw Fixation System

K-Number: K181824 · 2018-12-13

ApplicantU&I Corporation
Decision Date2018-12-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CBT Screw Fixation System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2018-12-13 under approval number K181824. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CBT Screw Fixation System?

CBT Screw Fixation System is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by U&I Corporation. The 510(k) number is K181824.

When was CBT Screw Fixation System approved by the FDA?

CBT Screw Fixation System received FDA 510(k) clearance on 2018-12-13, under approval number K181824.

What company makes CBT Screw Fixation System?

CBT Screw Fixation System is manufactured by U&I Corporation.

What is the FDA product code for CBT Screw Fixation System?

The FDA product code for CBT Screw Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by U&I Corporation

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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