DeviceClearance

COPAL exchange G Hip and Knee Spacers— 510(k) K191016

Substantially Equivalent

Heraeus Medical GmbH

FDA 510(k) clearance K191016 for COPAL exchange G Hip and Knee Spacers, Substantially Equivalent on 2019-11-01. Applicant: Heraeus Medical GmbH.

Clearance details

Applicant
Heraeus Medical GmbH
Product code
Code KWY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Werheim, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWY

product code KWY
Death
3
Injury
2,049
Total
2,052

Source: openFDA MAUDE database, through . 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.