510(k) K122011 ยท OLO Orthopedic Stereotaxic Instrument
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Nov 15, 2012 |
| Received | Jul 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122011
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2015 | Brainlab AG The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instr Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.