MITEK GII ANCHOR— 510(k) K953877

Substantially Equivalent

Mitek Surgical Products, Inc.

FDA 510(k) clearance K953877 for MITEK GII ANCHOR, Substantially Equivalent on 1995-12-29. Applicant: Mitek Surgical Products, Inc..

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1995-07-17
Decision date: 1995-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.