K233093
- 510(k) number
- K233093
- Device name
- Balanced Knee® System TriMax PS Plus Tibial Insert
- Applicant
- Ortho Development Corporation UT · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2023-10-25
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233093.pdf
Official FDA record: K233093
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.