ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)— 510(k) K040017

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K040017 for ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE), Substantially Equivalent on 2004-05-14. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2004-01-06
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.