K241564
- 510(k) number
- K241564
- Device name
- Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
- Applicant
- Baxter Healthcare Corporation IL · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2024-08-02
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241564.pdf
Official FDA record: K241564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.