iFuse Implant System(R)
K-Number: K152681 · 2016-03-01
ApplicantSI-BONE, Inc.
Decision Date2016-03-01
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
iFuse Implant System(R) is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2016-03-01 under approval number K152681. 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 iFuse Implant System(R)?
iFuse Implant System(R) is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by SI-BONE, Inc.. The 510(k) number is K152681.
When was iFuse Implant System(R) approved by the FDA?
iFuse Implant System(R) received FDA 510(k) clearance on 2016-03-01, under approval number K152681.
What company makes iFuse Implant System(R)?
iFuse Implant System(R) is manufactured by SI-BONE, Inc..
What is the FDA product code for iFuse Implant System(R)?
The FDA product code for iFuse Implant System(R) is OUR.
Related Clinical Trials
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05391828
Persona MC vs PS RCT With ROSA
RECRUITING
NCT06642935
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
ACTIVE_NOT_RECRUITING
NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
RECRUITING
NCT05855135
Assessment of Combined CCM and ICD Device in HFrEF
ACTIVE_NOT_RECRUITING
NCT07287124
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
RECRUITING
Related PubMed Literature
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.
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.
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.