510(k) K170620 ยท MQV Filler, Bone Void, Calcium Compound
ReBOSSIS85
| Applicant | Orthorebirth Co., Ltd., Yokohama, JP |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Orthorebirth Co Ltd BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC Open, Classified |
MQV | None listed |
| May 7, 2026 | Orthorebirth Co Ltd ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z Open, Classified |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.