K231188
- 510(k) number
- K231188
- Device name
- ALIGN Radial Head System
- Applicant
- Skeletal Dynamics, Inc. FL · US
- Product code
- KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
- Decision date
- 2023-09-28
- Date received
- 2023-04-26
- 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: K231188.pdf
Official FDA record: K231188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.