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FDA 510(k)

Fusion Compact Navigation System

K-Number: K153247 · 2016-02-18

ApplicantMedtronic Navigation, Inc.
Decision Date2016-02-18
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fusion Compact Navigation System is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-02-18 under approval number K153247. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Compact Navigation System?

Fusion Compact Navigation System is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K153247.

When was Fusion Compact Navigation System approved by the FDA?

Fusion Compact Navigation System received FDA 510(k) clearance on 2016-02-18, under approval number K153247.

What company makes Fusion Compact Navigation System?

Fusion Compact Navigation System is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Fusion Compact Navigation System?

The FDA product code for Fusion Compact Navigation System is PGW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

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)

Other Devices by Medtronic Navigation, Inc.

K162604Cranial Reducing Tubes K153660StealthStation System with Cranial Software K153555EM ENT Navigated Suctions K170018StealthStationTM S8 ENT Software K162655StealthConnect Remote Viewing, Planning and Collaboration System K162309StealthStation S8 System Platforms and StealthStation Cranial Software

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Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.

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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