SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)— 510(k) K992348

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K992348 for SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN), Substantially Equivalent on 1999-09-23. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 1999-07-14
Decision date: 1999-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.