510(k) K192335 ยท NDN Cement, Bone, Vertebroplasty
TRACKER Kyphoplasty System
| Applicant | GS Medical Co., Ltd., Osong-Eup, Cheongwon-Gun, KR |
| Decision | Substantially Equivalent, Dec 4, 2019 |
| Received | Aug 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192335
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.