Meridian Anterior Plate System, Regatta Lateral Plate System— 510(k) K200885
Substantially EquivalentSeaSpine Orthopedics Corporation
FDA 510(k) clearance K200885 for Meridian Anterior Plate System, Regatta Lateral Plate System, Substantially Equivalent on 2020-05-28. Applicant: SeaSpine Orthopedics Corporation.
Clearance details
- Applicant
- SeaSpine Orthopedics Corporation
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, 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.