K234028

Substantially Equivalent

COPAL® exchange G hip spacer; COPAL® G+V

Applicant: Heraeus Medical GmbH
Product code: KWL
Advisory panel: Orthopedic
Date received: 2023-12-20
Decision date: 2024-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wehrheim, DE

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.