K091041

Substantially Equivalent

RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS

Applicant: Depuy Mitek, A Johnson & Johnson Company
Product code: MAI
Advisory panel: Orthopedic
Date received: 2009-04-13
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, 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.