510(k) K200384 ยท OSF Patient Specific Manual Orthopedic Stereotaxic System
HipXpert 3D Display and Anchoring Application
| Applicant | Surgical Planning Associates, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Jan 28, 2021 |
| Received | Feb 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200384
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.