K243248
- 510(k) number
- K243248
- Device name
- INHANCE INTACT
- Applicant
- Depuy Ireland UC IE
- Product code
- PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Meta
- Decision date
- 2024-12-23
- Date received
- 2024-10-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243248.pdf
Official FDA record: K243248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.