Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orthorebirth Co., Ltd. with 4 510(k) clearances and 2 device recalls. The most recent is a device recall dated Mar 25, 2026: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 25, 2026 | ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-ZClass II · Resorbable bone void filler falls outside standard specifications. | Device recalls |
| Mar 25, 2026 | BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KCClass II · Resorbable bone void filler falls outside standard specifications. | Device recalls |
| Mar 4, 2024 | ReBOSSISK240453 · MQV | 510(k) clearances |
| Dec 15, 2017 | ReBOSSIS85K172573 · MQV | 510(k) clearances |
| Jun 23, 2017 | ReBOSSIS85K170620 · MQV | 510(k) clearances |
| Oct 29, 2014 | REBOSSISK142090 · MQV | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
