ARTOS, DIPLOS SYSTEM— 510(k) K970284

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K970284 for ARTOS, DIPLOS SYSTEM, Substantially Equivalent on 1997-04-21. Applicant: Turnkey Intergration USA, Inc..

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1997-01-24
Decision date: 1997-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.