K244015
- 510(k) number
- K244015
- Device name
- SuperBall-RC
- Applicant
- Arcuro Medical , Ltd. IL
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-02-19
- Date received
- 2024-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K244015.pdf
Official FDA record: K244015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.