510(k) K251959 ยท GXP Methyl Methacrylate For Cranioplasty
TnR Cranial Implant
| Applicant | T&R BIOFAB CO., Ltd., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Jul 30, 2026 |
| Received | Jun 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251959
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.