510(k) K050438 ยท HAW Neurological Stereotaxic Instrument
STEALTHSTATION SYSTEM UPDATE
| Applicant | Medtronic Surgical Navigation Technologies, Louisville CO, US |
| Decision | Substantially Equivalent, Jun 2, 2005 |
| Received | Feb 22, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | Medtronic Navigation, Inc. Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Terminated |
HAW | None listed |
| Jul 18, 2016 | Medtronic Navigation, Inc. Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid Terminated |
HAW | None listed |
| Jul 18, 2016 | Medtronic Navigation, Inc. MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid Terminated |
HAW | None listed |
| Sep 30, 2015 | Medtronic Navigation, Inc. P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLE Terminated |
HAW | None listed |
| Nov 29, 2012 | Medtronic Navigation, Inc. The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assi Terminated |
HAW | None listed |
| Jul 11, 2011 | Medtronic Navigation, Inc. DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthSta Terminated |
HAW | None listed |
| Mar 4, 2011 | Medtronic Navigation, Inc Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027.
The Polaris Spectra Position Sensor Unit (PSU) is the component of the S Terminated |
HAW | None listed |
| Feb 4, 2011 | Medtronic Navigation, Inc Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO.
Used in conjunction with the StealthSt Terminated |
HAW | None listed |
| Dec 17, 2010 | Medtronic Navigation, Inc Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027.
Intended as an aid for precisely locating anatomical structures in either Terminated |
HAW | None listed |
| Oct 26, 2010 | Medtronic Navigation, Inc Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.
To be used with a Medtronic C Terminated |
HAW | None listed |
| Jul 17, 2010 | Medtronic Navigation, Inc Medtronic StealthStation S7 System Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.