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FDA 510(k)

Ibis® Pedicle Screw System

K-Number: K162995 · 2017-03-30

ApplicantOrtho Development Corporation
Decision Date2017-03-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ibis® Pedicle Screw System is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2017-03-30 under approval number K162995. 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 Ibis® Pedicle Screw System?

Ibis® Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2017-03-30. It is manufactured by Ortho Development Corporation. The 510(k) number is K162995.

When was Ibis® Pedicle Screw System approved by the FDA?

Ibis® Pedicle Screw System received FDA 510(k) clearance on 2017-03-30, under approval number K162995.

What company makes Ibis® Pedicle Screw System?

Ibis® Pedicle Screw System is manufactured by Ortho Development Corporation.

What is the FDA product code for Ibis® Pedicle Screw System?

The FDA product code for Ibis® Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

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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