Integrity-SI® Fusion System
K-Number: K230226 · 2023-09-21
ApplicantOsteoCentric Technologies
Decision Date2023-09-21
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Integrity-SI® Fusion System is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-09-21 under approval number K230226. 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® Fusion System?
Integrity-SI® Fusion System is a medical device that received FDA 510(k) clearance on 2023-09-21. It is manufactured by OsteoCentric Technologies. The 510(k) number is K230226.
When was Integrity-SI® Fusion System approved by the FDA?
Integrity-SI® Fusion System received FDA 510(k) clearance on 2023-09-21, under approval number K230226.
What company makes Integrity-SI® Fusion System?
Integrity-SI® Fusion System is manufactured by OsteoCentric Technologies.
What is the FDA product code for Integrity-SI® Fusion System?
The FDA product code for Integrity-SI® 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WITHDRAWN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
Other Devices by OsteoCentric Technologies
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.