Cardinal Health External Fixation System— 510(k) K150579
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K150579 for Cardinal Health External Fixation System, Substantially Equivalent on 2015-04-29. Applicant: Cardinalhealth. Device class: 2.
Clearance details
- Applicant
- Cardinalhealth
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code KTT
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- 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 KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.