AVAflex Vertebral Balloon System— 510(k) K151125

Clearance details

Applicant

Care Fusion

Product code

Code HRX

Device class

Class 2

Regulation

21 CFR 888.1100

Advisory panel

Orthopedic

Date received

2015-04-28

Decision date

2015-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, US

• K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
• K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
• K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
• K253523 — Freedom DS Decompression System2026-04-16
• K252546 — VantageTM Lumbar Decompression Kit2026-03-12

• K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device2024-03-06
• K231888 — BD Texium Needle-Free Syringe2023-09-25
• K221319 — BD Alaris Pump Epidural Infusion Set2023-07-21
• K221327 — BD Alaris Pump Infusion Sets2023-07-21
• K223101 — BD Secondary Infusion Set2023-05-12

Injury

623

Malfunction

11,257

Total

11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →