DeviceClearance

COPAL knee moulds— 510(k) K222570

Substantially Equivalent

Heraeus Medical GmbH

FDA 510(k) clearance K222570 for COPAL knee moulds, Substantially Equivalent on 2023-02-04. Applicant: Heraeus Medical GmbH.

Clearance details

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

Adverse events under product code JWH

product code JWH
Death
26
Injury
51,564
Malfunction
9,725
Other
9
Total
61,324

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.