K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)— 510(k) K023770

Substantially Equivalent

Kinetikos Medical, Inc.

FDA 510(k) clearance K023770 for K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM), Substantially Equivalent on 2002-12-12. Applicant: Kinetikos Medical, Inc..

Clearance details

Applicant: Kinetikos Medical, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2002-11-12
Decision date: 2002-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.