Data / Medical devices / Japan / Orthorebirth Co., Ltd.
Orthorebirth Co., Ltd.: FDA-registered device maker in Yokohama Kanagawa, Japan, 3 510(k) clearances
Orthorebirth Co., Ltd. is registered with the FDA (registration 3011415547) in Yokohama Kanagawa, Japan. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 4, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011415547
- Address
- 15-3-303 Chigasaki-chuo, Tsuzuki-ku, Yokohama Kanagawa, Japan, 224-0032
- Owner or operator
- ORTHOREBIRTH Co., Ltd. (10048526)
- Roles
- Exporter to the US, Specification developer
- First device listed
- September 8, 2017
- Registered through
- 2026
- Brand names listed
- ReBOSSIS, ReBOSSIS QDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 4, 2024 | K240453 | ReBOSSIS | MQV | Substantially Equivalent | Orthorebirth Co., Ltd. | accessdata.fda.gov |
| December 15, 2017 | K172573 | ReBOSSIS85 | MQV | Substantially Equivalent | Orthorebirth Co., Ltd. | accessdata.fda.gov |
| June 23, 2017 | K170620 | ReBOSSIS85 | MQV | Substantially Equivalent | Orthorebirth Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 25, 2026 | 98733 | Class II | Ongoing | BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC | Resorbable bone void filler falls outside standard specifications. | accessdata.fda.gov |
Compare with other makers
Updated May 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.