LINK CERCLAGE WIRE SYSTEM— 510(k) K970084

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K970084 for LINK CERCLAGE WIRE SYSTEM, Substantially Equivalent on 1997-03-13. Applicant: Turnkey Intergration USA, Inc..

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 1997-01-09
Decision date: 1997-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.