K233148
- 510(k) number
- K233148
- Device name
- Augment Off-Axis Instrument System
- Applicant
- Fix Surgical PA · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2024-03-22
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233148.pdf
Official FDA record: K233148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.