K231445
- 510(k) number
- K231445
- Device name
- LINK Embrace Shoulder System - Reverse Configuration
- Applicant
- Waldemar Link GmbH & Co. KG DE
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2023-11-16
- Date received
- 2023-05-18
- 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: K231445.pdf
Official FDA record: K231445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.