510(k) K182285 ยท KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
PK High Tibial Osteotomy Correction System
| Applicant | Paonan Biotech Co., Ltd., Taipei City, TW |
| Decision | Substantially Equivalent, Jun 20, 2019 |
| Received | Aug 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182285
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.