K241709
- 510(k) number
- K241709
- Device name
- Pectus Blu Support Bar System
- Applicant
- Biomet Microfixation FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-09-19
- Date received
- 2024-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K241709.pdf
Official FDA record: K241709
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.