K230591
- 510(k) number
- K230591
- Device name
- TriLEAP Plating System
- Applicant
- Crossroads Extremity Systems TN · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2023-09-29
- Date received
- 2023-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K230591.pdf
Official FDA record: K230591
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.