SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS— 510(k) K033411

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K033411 for SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS, Substantially Equivalent on 2003-11-26. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2003-10-27
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Paoli, PA, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.