NovoStitch Pro Meniscal Repair System— 510(k) K180531

Substantially Equivalent

Ceterix Orthopaedics, Inc.

FDA 510(k) clearance K180531 for NovoStitch Pro Meniscal Repair System, Substantially Equivalent on 2018-03-29. Applicant: Ceterix Orthopaedics, Inc..

Clearance details

Applicant: Ceterix Orthopaedics, Inc.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2018-02-28
Decision date: 2018-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.