SYNTHES IN-SITU BENDER/CUTTER— 510(k) K021458

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K021458 for SYNTHES IN-SITU BENDER/CUTTER, Substantially Equivalent on 2002-07-24. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2002-05-07
Decision date: 2002-07-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Paoli, PA, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.