SYNTHES BUTTON PLATE— 510(k) K994364

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K994364 for SYNTHES BUTTON PLATE, Substantially Equivalent on 2000-03-15. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1999-12-27
Decision date: 2000-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.