K261002
- 510(k) number
- K261002
- Device name
- Pectus Blu System
- Applicant
- Biomet Microfixation FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-06-02
- Date received
- 2026-03-26
- 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: K261002.pdf
Official FDA record: K261002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.