K231699
- 510(k) number
- K231699
- Device name
- QUANTUM® Patient Specific Instrumentation (PSI) System
- Applicant
- In2bones Sas FR
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2024-04-23
- Date received
- 2023-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231699.pdf
Official FDA record: K231699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.