SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)— 510(k) K042135

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K042135 for SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION), Substantially Equivalent on 2004-10-07. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2004-08-09
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.