K240453
- 510(k) number
- K240453
- Device name
- ReBOSSIS
- Applicant
- Orthorebirth Co., Ltd. JP
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2024-03-04
- Date received
- 2024-02-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240453.pdf
Official FDA record: K240453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.