Fusion Compact ™
Fusion Compact is a computer-assisted navigation platform for locating anatomy during ENT surgery. Its computer reformats patient-specific CT or MR images into axial, sagittal and coronal…
Fusion Compact is a computer-assisted navigation platform for locating anatomy during ENT surgery. Its computer reformats patient-specific CT or MR images into axial, sagittal and coronal views and displays tracked surgical probe positions on them.
The platform combines navigation software, a referencing system and computer hardware. Electromagnetic localization continuously updates the positions of compatible instruments relative to surgical anatomy during the procedure.
Listed Item
Computer 9735602R Fusion Comp RFB Loaded
ENT Navigation
The system uses an all-in-one monitor and computer with an emitter-holder option. It supports medical-office or operating-room procedures including endoscopic and lateral skull-base surgery and functional endoscopic sinus surgery, requiring a rigid anatomical reference identifiable on the images.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K153247 |
| Record published | 2018-06-17 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9735602R | In distribution | |
| 9735550 | In distribution | |
| 9735602 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | Karl Storz GmbH & Co. KG | 17 |
| StealthStation | Medtronic Navigation, Inc. | 17 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 14 |
| Ear, Nose, And Throat Stereotaxic Instrument | Medtronic Navigation, Inc. | 13 |
| Ear, Nose, And Throat Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 12 |
| StealthStation Cranial Software | Medtronic Navigation, Inc. | 11 |
| AxiEM™ | Medtronic Navigation, Inc. | 10 |
| Profess | Stryker Leibinger Gmbh & Co. KG | 8 |
| TGS | Stryker GmbH | 6 |
| StealthStation S8 | Medtronic Navigation, Inc. | 5 |
| TruDi Probe | Acclarent, Inc. | 4 |
| TruDi Shaver Blade | Acclarent, Inc. | 4 |
Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253395 | 2026-03-16 |
| K200723 | 2020-06-26 |
| K170018 | 2017-05-19 |
| K153555 | 2016-04-07 |
| K153247 | 2016-02-18 |
| K133665 | 2014-03-13 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 149 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 6 kits | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 8 kits | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 277 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 60 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 75 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 15 kits | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 13 kits | 2018-08-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.