510(k) K153207 ยท HRS Plate, Fixation, Bone
Additive Orthopaedics Bone Wedge System
| Applicant | Additive Orthopaedics, LLC, Little Silver NJ, US |
| Decision | Substantially Equivalent, Sep 7, 2016 |
| Received | Nov 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153207
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.