MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI— 510(k) K111792

Substantially Equivalent

Signus Medizintechnik GmbH

FDA 510(k) clearance K111792 for MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI, Substantially Equivalent on 2012-03-05. Applicant: Signus Medizintechnik GmbH.

Clearance details

Applicant: Signus Medizintechnik GmbH
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2011-06-27
Decision date: 2012-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.