510(k) K193312 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
UNIKO PointCloud Knee Instruments
| Applicant | Unik Orthopedics, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Aug 12, 2020 |
| Received | Nov 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193312
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.