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FDA 510(k)

Integrity-SI TM Fusion System

K-Number: K161755 · 2016-12-14

ApplicantCoorstek Medical
Decision Date2016-12-14
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integrity-SI TM Fusion System is a medical device manufactured by Coorstek Medical. It received FDA 510(k) clearance on 2016-12-14 under approval number K161755. 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 Integrity-SI TM Fusion System?

Integrity-SI TM Fusion System is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Coorstek Medical. The 510(k) number is K161755.

When was Integrity-SI TM Fusion System approved by the FDA?

Integrity-SI TM Fusion System received FDA 510(k) clearance on 2016-12-14, under approval number K161755.

What company makes Integrity-SI TM Fusion System?

Integrity-SI TM Fusion System is manufactured by Coorstek Medical.

What is the FDA product code for Integrity-SI TM Fusion System?

The FDA product code for Integrity-SI TM Fusion System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT03466151 RESOLUTE ONYX China RCT Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026)

Related Devices (Code: OUR)

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 K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.

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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