COPAL exchange G hip spacer— 510(k) K220492

Substantially Equivalent

Heraeus Medical GmbH

FDA 510(k) clearance K220492 for COPAL exchange G hip spacer, Substantially Equivalent on 2022-03-23. Applicant: Heraeus Medical GmbH.

Clearance details

Applicant: Heraeus Medical GmbH
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2022-02-22
Decision date: 2022-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Wehrheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.