K241167
- 510(k) number
- K241167
- Device name
- BioSphere Putty; BioSphere MIS Putty
- Applicant
- Synergy Biomedical PA · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2024-12-20
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241167.pdf
Official FDA record: K241167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.