510(k) K070106 ยท HAW Neurological Stereotaxic Instrument
VV FLUORO 3D
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Apr 23, 2007 |
| Received | Jan 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2019 | Brainlab AG Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )
Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image Terminated |
HAW | None listed |
| Nov 16, 2017 | Brainlab AG Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left Terminated |
HAW | None listed |
| Nov 17, 2015 | Brainlab AG BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localizat Terminated |
HAW | None listed |
| Aug 13, 2014 | Brainlab AG Navigation Spine & Trauma 3D Version 2.0 and 2.1
Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passi Terminated |
HAW | None listed |
| Apr 17, 2014 | Brainlab AG Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.