510(k) K212245 ยท OLO Orthopedic Stereotaxic Instrument
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Jul 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212245
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.