510(k) K182059 ยท NKB Thoracolumbosacral Pedicle Screw System
Prase MIS Spinal System
| Applicant | Gbs Commonwealth Co., Ltd., Geumcheon-Gu, KR |
| Decision | Substantially Equivalent, Oct 4, 2018 |
| Received | Jul 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182059
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.