510(k) K162375 ยท OLO Orthopedic Stereotaxic Instrument
Envision 3D: Image Guidance System
| Applicant | 7D Surgical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Dec 29, 2016 |
| Received | Aug 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162375
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.