K242984
- 510(k) number
- K242984
- Device name
- BKS Revision System
- Applicant
- Ortho Development Corp. UT · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-10-25
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K242984.pdf
Official FDA record: K242984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.