QUANTUM® Patient Specific Instrumentation (PSI) System— 510(k) K231699

Substantially Equivalent

In2bones Sas

FDA 510(k) clearance K231699 for QUANTUM® Patient Specific Instrumentation (PSI) System, Substantially Equivalent on 2024-04-23. Applicant: In2bones Sas.

Clearance details

Applicant: In2bones Sas
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2023-06-12
Decision date: 2024-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ecully, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.