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FDA 510(k)

Black Diamond Pedicle Screw System

K-Number: K192121 · 2019-10-29

ApplicantOsseus Fusion Systems
Decision Date2019-10-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Black Diamond Pedicle Screw System is a medical device manufactured by Osseus Fusion Systems. It received FDA 510(k) clearance on 2019-10-29 under approval number K192121. 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 Black Diamond Pedicle Screw System?

Black Diamond Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Osseus Fusion Systems. The 510(k) number is K192121.

When was Black Diamond Pedicle Screw System approved by the FDA?

Black Diamond Pedicle Screw System received FDA 510(k) clearance on 2019-10-29, under approval number K192121.

What company makes Black Diamond Pedicle Screw System?

Black Diamond Pedicle Screw System is manufactured by Osseus Fusion Systems.

What is the FDA product code for Black Diamond Pedicle Screw System?

The FDA product code for Black Diamond 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 NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT05856799 Danish Randomized Trial on Leadless vs Transvenous Pacing ACTIVE_NOT_RECRUITING 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

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)

Other Devices by Osseus Fusion Systems

K192495Black Diamond Navigation Instruments K222107Black Diamond™ POCT Spinal System K213935PISCES-SA Standalone ALIF Interbody System K223413Pisces™-SA STANDALONE ALIF Interbody System

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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