K243308
- 510(k) number
- K243308
- Device name
- Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
- Applicant
- Bonebridge AG CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-12-20
- Date received
- 2024-10-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K243308.pdf
Official FDA record: K243308
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.