Cardinal Health Trochanteric IM Nail System— 510(k) K150769
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K150769 for Cardinal Health Trochanteric IM Nail System, Substantially Equivalent on 2015-12-14. Applicant: Cardinalhealth. Device class: 2.
Clearance details
- Applicant
- Cardinalhealth
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Cardinalhealth
view all- K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff
- K243660 — Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) +8 more
- K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)
- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.