TETRIS II— 510(k) K122317

Substantially Equivalent

Signus Medizintechnik GmbH

FDA 510(k) clearance K122317 for TETRIS II, Substantially Equivalent on 2012-08-29. Applicant: Signus Medizintechnik GmbH.

Clearance details

Applicant: Signus Medizintechnik GmbH
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2012-08-01
Decision date: 2012-08-29
Decision: Substantially Equivalent
Clearance type: Special
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.