K233670
- 510(k) number
- K233670
- Device name
- Ascension Silicone MCP; Ascension Silicone PIP
- Applicant
- Ascension Orthopedics, Inc. TX · US
- Product code
- KYJ — Prosthesis, Finger, Constrained, Polymer
- Decision date
- 2023-12-14
- Date received
- 2023-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233670.pdf
Official FDA record: K233670
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.