MITEK ANCHOR DRILL— 510(k) K892903

Substantially Equivalent

Mitek Surgical Products, Inc.

FDA 510(k) clearance K892903 for MITEK ANCHOR DRILL, Substantially Equivalent on 1989-10-06. Applicant: Mitek Surgical Products, Inc..

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code HTW
Advisory panel: Orthopedic
Date received: 1989-04-20
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dedham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

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.