510(k) K121765 ยท OLO Orthopedic Stereotaxic Instrument
SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
| Applicant | Stanmore Implants Worldwide , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Jan 11, 2013 |
| Received | Jun 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121765
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.