OMNI-FIX, HUMERAL NAIL— 510(k) K991405

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K991405 for OMNI-FIX, HUMERAL NAIL, Substantially Equivalent on 1999-06-29. Applicant: Turnkey Intergration USA, Inc..

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 1999-04-22
Decision date: 1999-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.