GREAT TOE IMPLANT SYSTEM— 510(k) K014164

Substantially Equivalent

Harmos Orthopaedics, Inc.

FDA 510(k) clearance K014164 for GREAT TOE IMPLANT SYSTEM, Substantially Equivalent on 2002-03-12. Applicant: Harmos Orthopaedics, Inc..

Clearance details

Applicant: Harmos Orthopaedics, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2001-12-19
Decision date: 2002-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cantonville, MD, US

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.