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FDA 510(k)

C-Zero Pedicle Screw System, Freedom Pedicle Screw System

K-Number: K180754 · 2018-12-07

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2018-12-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

C-Zero Pedicle Screw System, Freedom Pedicle Screw System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2018-12-07 under approval number K180754. 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 C-Zero Pedicle Screw System, Freedom Pedicle Screw System?

C-Zero Pedicle Screw System, Freedom Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K180754.

When was C-Zero Pedicle Screw System, Freedom Pedicle Screw System approved by the FDA?

C-Zero Pedicle Screw System, Freedom Pedicle Screw System received FDA 510(k) clearance on 2018-12-07, under approval number K180754.

What company makes C-Zero Pedicle Screw System, Freedom Pedicle Screw System?

C-Zero Pedicle Screw System, Freedom Pedicle Screw System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for C-Zero Pedicle Screw System, Freedom Pedicle Screw System?

The FDA product code for C-Zero Pedicle Screw System, Freedom Pedicle Screw System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

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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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