mont blanc & mont blanc MIS Spinal Systems— 510(k) K191726

Substantially Equivalent

Spineway SA

FDA 510(k) clearance K191726 for mont blanc & mont blanc MIS Spinal Systems, Substantially Equivalent on 2019-09-12. Applicant: Spineway SA.

Clearance details

Applicant: Spineway SA
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2019-06-27
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ecully, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.