BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT— 510(k) K992394

Substantially Equivalent

Endotec, Inc.

FDA 510(k) clearance K992394 for BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT, Substantially Equivalent on 1999-10-15. Applicant: Endotec, Inc..

Clearance details

Applicant: Endotec, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 1999-07-19
Decision date: 1999-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Orange, NJ, US

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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.