HIGH V+— 510(k) K161114

Substantially Equivalent

Teknimed Sas

FDA 510(k) clearance K161114 for HIGH V+, Substantially Equivalent on 2017-04-12. Applicant: Teknimed Sas.

Clearance details

Applicant: Teknimed Sas
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2016-04-20
Decision date: 2017-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: L'Union, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.