IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved— 510(k) K153087

Substantially Equivalent

Ivy Sports Medicine, LLC

FDA 510(k) clearance K153087 for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved, Substantially Equivalent on 2016-07-14. Applicant: Ivy Sports Medicine, LLC.

Clearance details

Applicant: Ivy Sports Medicine, LLC
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2015-10-26
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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.