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FDA 510(k)

Blue Topaz Sacroiliac Screw System

K-Number: K213590 · 2022-03-01

ApplicantOsseus Fusion Systems, LLC
Decision Date2022-03-01
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Blue Topaz Sacroiliac Screw System is a medical device manufactured by Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2022-03-01 under approval number K213590. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blue Topaz Sacroiliac Screw System?

Blue Topaz Sacroiliac Screw System is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Osseus Fusion Systems, LLC. The 510(k) number is K213590.

When was Blue Topaz Sacroiliac Screw System approved by the FDA?

Blue Topaz Sacroiliac Screw System received FDA 510(k) clearance on 2022-03-01, under approval number K213590.

What company makes Blue Topaz Sacroiliac Screw System?

Blue Topaz Sacroiliac Screw System is manufactured by Osseus Fusion Systems, LLC.

What is the FDA product code for Blue Topaz Sacroiliac Screw System?

The FDA product code for Blue Topaz Sacroiliac Screw System is OUR.

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 NCT07528326 The TRICURE US IDE Pivotal Study NOT_YET_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 NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Other Devices by Osseus Fusion Systems, LLC

K160522White Pearl Preferred Angle Anterior Cervical Plate K170844Gemini-C Hybrid Cervical Interbody System K181347Aries® Lumbar Interbodies

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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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