K233025
- 510(k) number
- K233025
- Device name
- Revolution External Plating System
- Applicant
- New Standard Device Dba Metalogix TX · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2024-05-30
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233025.pdf
Official FDA record: K233025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.