K242091
- 510(k) number
- K242091
- Device name
- Bolo Button System
- Applicant
- Fusion Orthopedics AZ · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2024-12-23
- Date received
- 2024-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242091.pdf
Official FDA record: K242091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.