K241260
- 510(k) number
- K241260
- Device name
- ACTIFY Unicondylar Knee System
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cem
- Decision date
- 2024-12-06
- Date received
- 2024-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241260.pdf
Official FDA record: K241260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.