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FDA 510(k)

iFuse Implant System - iFuse Navigation

K-Number: K203110 · 2020-11-09

ApplicantSI-BONE, Inc.
Decision Date2020-11-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iFuse Implant System - iFuse Navigation is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2020-11-09 under approval number K203110. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iFuse Implant System - iFuse Navigation?

iFuse Implant System - iFuse Navigation is a medical device that received FDA 510(k) clearance on 2020-11-09. It is manufactured by SI-BONE, Inc.. The 510(k) number is K203110.

When was iFuse Implant System - iFuse Navigation approved by the FDA?

iFuse Implant System - iFuse Navigation received FDA 510(k) clearance on 2020-11-09, under approval number K203110.

What company makes iFuse Implant System - iFuse Navigation?

iFuse Implant System - iFuse Navigation is manufactured by SI-BONE, Inc..

What is the FDA product code for iFuse Implant System - iFuse Navigation?

The FDA product code for iFuse Implant System - iFuse Navigation is OLO.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by SI-BONE, Inc.

K161893Neuromonitoring Kit K160652iFUSE Implant System K152681iFuse Implant System(R) K172268iFuse Implant System- iFuse Navigation K162733iFuse Implant System® - iFuse-3D implant K182983iFuse Implant System®

View all 22 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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