K240856
- 510(k) number
- K240856
- Device name
- Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
- Applicant
- Osartis GmbH DE
- Product code
- MBB — Bone Cement, Antibiotic
- Decision date
- 2024-11-20
- Date received
- 2024-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K240856.pdf
Official FDA record: K240856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.