510(k) K211797 ยท NDN Cement, Bone, Vertebroplasty
TRACKER Plus Kyphoplasty System
| Applicant | GS Medical Co., Ltd., Cheongju-Si, KR |
| Decision | Substantially Equivalent, Oct 28, 2021 |
| Received | Jun 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211797
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.