510(k) K181854 ยท DZL Screw, Fixation, Intraosseous
OssBuilder System
| Applicant | Osstem Implant Co., Ltd., Busan, KR |
| Decision | Substantially Equivalent, May 7, 2019 |
| Received | Jul 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181854
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.