CURVED PEEK TETRIS SPINAL IMPLANT— 510(k) K041888

Substantially Equivalent

Signus Medizintechnik GmbH

FDA 510(k) clearance K041888 for CURVED PEEK TETRIS SPINAL IMPLANT, Substantially Equivalent on 2004-08-10. Applicant: Signus Medizintechnik GmbH.

Clearance details

Applicant: Signus Medizintechnik GmbH
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2004-07-12
Decision date: 2004-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.