BUECHEL-PAPPAS HUMERAL STEM COMPONENT— 510(k) K904880

Substantially Equivalent

Endotec, Inc.

FDA 510(k) clearance K904880 for BUECHEL-PAPPAS HUMERAL STEM COMPONENT, Substantially Equivalent on 1991-01-28. Applicant: Endotec, Inc..

Clearance details

Applicant: Endotec, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 1990-10-30
Decision date: 1991-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Orange, NJ, US

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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.