510(k) K163486 · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates
| Applicant | Hnm Total Recon, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Jul 24, 2017 |
| Received | Dec 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163486
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.