K240327
- 510(k) number
- K240327
- Device name
- UNIKO PointCloud Knee Instruments
- Applicant
- Unik Orthopedics, Inc. CA · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-06-27
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240327.pdf
Official FDA record: K240327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.