ECLIPSE TOTAL ANKLE IMPLANT— 510(k) K061749

Substantially Equivalent

Kinetikos Medical, Inc.

FDA 510(k) clearance K061749 for ECLIPSE TOTAL ANKLE IMPLANT, Substantially Equivalent on 2006-11-22. Applicant: Kinetikos Medical, Inc..

Clearance details

Applicant: Kinetikos Medical, Inc.
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2006-06-21
Decision date: 2006-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

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.