K243624
- 510(k) number
- K243624
- Device name
- Acu-Sinch Knotless Mini
- Applicant
- Acumed, LLC OR · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2025-01-23
- Date received
- 2024-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243624.pdf
Official FDA record: K243624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.