510(k) K233989— CarboClear® Posterior Cervical Screw System
Substantially EquivalentCarboFix Orthopedics , Ltd.
Clearance details
- Applicant
- CarboFix Orthopedics , Ltd.
- Product code
- Code NKG
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Herzeliya, IL
Adverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
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.