MOBIS SPINAL IMPLANT— 510(k) K061082

Substantially Equivalent

Signus Medizintechnik GmbH

FDA 510(k) clearance K061082 for MOBIS SPINAL IMPLANT, Substantially Equivalent on 2006-12-18. Applicant: Signus Medizintechnik GmbH.

Clearance details

Applicant: Signus Medizintechnik GmbH
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2006-04-18
Decision date: 2006-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.