K243491
- 510(k) number
- K243491
- Device name
- SternalPlate Expansion
- Applicant
- Stryker Leibinger GmbH & Co KG DE
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-12-11
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243491.pdf
Official FDA record: K243491
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.