510(k) K180239 ยท HRS Plate, Fixation, Bone
Additive Orthopaedics Patient Specific 3D Printed Bone Segments
| Applicant | Additive Orthopaedics, LLC, Little Silver NJ, US |
| Decision | Substantially Equivalent, May 16, 2018 |
| Received | Jan 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180239
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.