K241043
- 510(k) number
- K241043
- Device name
- Augment Off-Axis Instrument System
- Applicant
- Fix Surgical PA · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2024-05-15
- Date received
- 2024-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241043.pdf
Official FDA record: K241043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.