K233994
- 510(k) number
- K233994
- Device name
- VOLT Proximal Humerus 3.5 Plating System
- Applicant
- Synthes GmbH CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-07-26
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233994.pdf
Official FDA record: K233994
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.