K240318
- 510(k) number
- K240318
- Device name
- SITTER 3.5mm Versatile System
- Applicant
- Bonebridge AG CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-08-23
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240318.pdf
Official FDA record: K240318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.