K234028
- 510(k) number
- K234028
- Device name
- COPAL® exchange G hip spacer; COPAL® G+V
- Applicant
- Heraeus Medical GmbH DE
- Product code
- KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
- Decision date
- 2024-02-15
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K234028.pdf
Official FDA record: K234028
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.