K161032

Substantially Equivalent

neon3 universal OCT spinal stabilization

Applicant: Ulrich GmbH & Co. KG
Product code: NKG
Advisory panel: Orthopedic
Date received: 2016-04-13
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ulm, DE

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.