COPAL® exchange G hip spacer; COPAL® G+V— 510(k) K234028
Substantially EquivalentHeraeus Medical GmbH
FDA 510(k) clearance K234028 for COPAL® exchange G hip spacer; COPAL® G+V, Substantially Equivalent on 2024-02-15. Applicant: Heraeus Medical GmbH.
Clearance details
- Applicant
- Heraeus Medical GmbH
- Product code
- Code KWL
- Advisory panel
- Orthopedic
- Date received
- Decision date
- 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, 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.