Fx Solutions
Fx Solutions holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2017, with 2 FDA device recalls on record.
Top product codes for Fx Solutions
FDA recalls by Fx Solutions
- Z-2469-2018 — Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Z-2468-2018 — Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Fx Solutions
- K163669 — Humeris Shoulder
- K162455 — Humelock Reversed Shoulder
- K150488 — Humelock II Reversible Shoulder System
- K143721 — PRCT2
- K140071 — HUMELOCK II CEMENTED SHOULDER SYSTEM
- K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM
- K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM
- K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.