510(k) K100038 ยท HAW Neurological Stereotaxic Instrument
DISPOSABLE REFLECTIVE MARKER SPHERES
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Jul 14, 2010 |
| Received | Jan 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2015 | Brainlab AG Disposable Reflective Marker Spheres
The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for preci Terminated |
HAW | None listed |
| Jul 16, 2015 | Northern Digital Inc. NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system.
Product Usage:
Disposable reflective marker spheres are attached to reference arrays and instruments, thus Terminated |
HAW | None listed |
| Jul 16, 2015 | Northern Digital Inc. NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system.
Product Usage:
Disposable reflective marker spheres are attached to reference arrays and instruments, thus ena Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.