MITEK 2GII MENISCAL REPAIR SYSTEM— 510(k) K002406

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K002406 for MITEK 2GII MENISCAL REPAIR SYSTEM, Substantially Equivalent on 2001-02-15. Applicant: Mitek Products.

Clearance details

Applicant: Mitek Products
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2000-08-07
Decision date: 2001-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

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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.