White Pearl Preferred Angle Anterior Cervical Plate— 510(k) K160522
Substantially EquivalentOsseus Fusion Systems, LLC
FDA 510(k) clearance K160522 for White Pearl Preferred Angle Anterior Cervical Plate, Substantially Equivalent on 2016-04-26. Applicant: Osseus Fusion Systems, LLC.
Clearance details
- Applicant
- Osseus Fusion Systems, LLC
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.