K231911
- 510(k) number
- K231911
- Device name
- Glenoid Reconstruction System Full Wedge Baseplate
- Applicant
- Medacta International S.A. CH
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2023-11-09
- Date received
- 2023-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K231911.pdf
Official FDA record: K231911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.