K200725

Substantially Equivalent

Citregen Tendon Interference Screw and Citrelock

Applicant: Acuitive Technologies
Product code: MAI
Advisory panel: Orthopedic
Date received: 2020-03-19
Decision date: 2020-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alendale, NJ, US

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.