SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION— 510(k) K081700

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K081700 for SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION, Substantially Equivalent on 2008-07-17. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2008-06-17
Decision date: 2008-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, PA, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.